orthopaedic & rheumatologic institute · treatment protocols utilizing randomized clinical...

11

Outcomes | 2007

Orthopaedic & Rheumatologic

Institute

Patients First

Orthopaedic & Rheumatologic Institute1

Outcomes 2007

Quality counts when referring patients to hospitals and physicians, so Cleveland Clinic has created a series of Outcomes

books similar to this one for many of its institutes. Designed for a healthcare provider audience, the Outcomes books

contain a summary of our surgical and medical trends and approaches, data on patient volume and outcomes, and a

review of new technologies and innovations.

Although we are unable to report all outcomes for all treatments provided at Cleveland Clinic — omission of outcomes

for a particular treatment does not mean we necessarily do not offer that treatment — our goal is to increase outcomes

reporting each year. When outcomes for a specific treatment are unavailable, we often report process measures that

have documented relationships with improved outcomes. When process measures are unavailable, we report volume

measures; a volume/outcome relationship has been demonstrated for many treatments, particularly those involving surgical

technique.

Cleveland Clinic also supports transparent public reporting of healthcare quality data and participates in the following

public reporting initiatives:

• Joint Commission Performance Measurement Initiative (www.qualitycheck.org)

• Centers for Medicare and Medicaid (CMS) Hospital Compare (www.hospitalcompare.hhs.gov)

• Leapfrog Group (www.leapfroggroup.org)

• Ohio Department of Health Service Reporting (www.odh.state.oh.us)

Our commitment to providing accurate, timely information about patient care is designed to help patients and referring

physicians make informed healthcare decisions. We hope you find these data valuable. To view all our Outcomes books,

visit Cleveland Clinic’s Quality and Patient Safety website at clevelandclinic.org/quality/outcomes.

22

Dear Colleague:

I am proud to present the 2007 Cleveland Clinic Outcomes books. These books provide information on results, volumes and innovations

related to Cleveland Clinic care. The books are designed to help you and your patients make informed decisions about treatments and

referrals.

Over the past year, we enhanced our ability to measure outcomes by reorganizing our clinical services into patient-centered institutes. Each

institute combines all the specialties and support services associated with a specific disease or organ system under a single leadership at a

single site. Institutes promote collaboration, encourage innovation and improve patient experience. They make it easier to benchmark and

collect outcomes, as well as implement data-driven changes.

Measuring and reporting outcomes reinforces our commitment to enhancing care and achieving excellence for our patients and referring

physicians. With the institutes model in place, we anticipate greater transparency and more comprehensive outcomes reporting.

Thank you for your interest in Cleveland Clinic’s Outcomes books. I hope you will continue to find them useful.

Sincerely,

Delos M. Cosgrove, MD

CEO and President

what’s insideChairman’s Letter 04

Institute Overview 05

Quality and Outcomes Measures

Orthopaedic Volumes and Outcomes 07

Rheumatology 31

Anesthesiology 39

Surgical Quality Improvement 41

Patient Experience 45

Innovations 47

New Knowledge 58

Staff Listing 64

Contact Information 67

Institute Locations 67

Cleveland Clinic Overview 69

Online Services 69 eCleveland Clinic DrConnect MyConsult

Outcomes 2007 44

Chairman’s LetterThe 2007 Orthopaedic and Rheumatologic Institute Outcomes book is the work product of many clinicians and clinical research staff. Over the last three years, we have expanded our capability to collect clinical outcome data on all surgical patients being treated on our main campus and have started to collect this same data at all of our clinical care sites within Northeast Ohio. In 2008, we will begin data collection for surgical patients being treated at our Florida Hospital in Westin.

Our Orthopaedic Surgery Department has used a standardized minimum data set that consists of the SF12 and a Musculoskeletal Quality of Life outcome tool. In addition, we utilize a joint specific outcome tool for all patients with hip, knee and shoulder surgery. We are expanding this in 2008 to include foot and ankle and pediatric conditions. All data is collected as part of the standard patient clinic visit before and after surgical treatment. Data is analyzed for all patients based upon the type of procedure performed for a specified length of follow-up that is considered to be clinically relevant to the type of surgery performed. In this publication we present data for total hip, knee and shoulder arthroplasty. We present outcome data for ACL reconstruction, rotator cuff repair, hip arthroscopy and arthroscopic meniscectomy. We also report clinical volume data, preoperative antibiotic administration, re-admission rates within 30 days of discharge, infection rates and patient satisfaction data.

Our Rheumatology Department is a leader in the evaluation and treatment of connective tissue diseases, including vasculitis, autoinflamatory diseases, metabolic bone diseases and scleroderma, and coordination of care with cardiovascular medicine, orthopaedics, pathology, imaging and surgery. The Vasculitis Center is conducting studies of novel treatment protocols utilizing randomized clinical trials. The Fasenmeyer Center for Clinical Immunology has promoted innovative research in vasculitis and viral-associated immune disorders, education and training for clinical immunology, and community outreach and awareness of public health issues. The Center for Osteoporosis and Metabolic Bone Diseases is evaluating novel biologic and anabolic therapy for osteoporosis. The Section of Pediatric Rheumatology has started a combined fellowship program with Case Western Reserve University’s rheumatology program, and established links with the NIH and the Autoinflammatory Disease Clinic. Cardiovascular outcomes in patients with rheumatic diseases is an ongoing focus of research. This year’s Outcomes book highlights the clinical outcomes of patients with osteoporosis, inflammatory arthritis, Wegeners

granulomatosis and giant cell arteritis.

Joseph P. Iannotti, MD, PhD

Orthopaedic and Rheumatologic Institute

5 Orthopaedic & Rheumatologic Institute5

42

26

3

professional teams worldwide

who sent an athlete for

treatment by the Orthopaedic

and Rheumatologic Institute

area high schools with

Cleveland Clinic Sports

Medicine coverage

professional sports teams

served by Cleveland Clinic

Sports Medicine (Cleveland

Browns, Cleveland Indians,

Cleveland Cavaliers)

Institute OverviewThe mission of the Orthopaedic and Rheumatologic Institute is to provide world-class, compassionate care and

world-class service to all patients seeking treatment at Cleveland Clinic. Serving patients is our first and most

important priority. We provide care for patients with the most complex clinical problems from around the country

and the world. Our Institute is dedicated to the education and training of our residents and fellows as well as

our colleagues both within and outside of Cleveland Clinic. Our goal is to select and train individuals interested

in remaining academically productive so that they contribute back to our profession through their own teaching

and research. Our Institute is also dedicated to the development of new knowledge and innovation through both

basic science and clinical research activities. Our current full-time faculty includes 42 orthopaedic surgeons (37

orthopaedic + 5 spine), 29 rheumatologists, 12 musculoskeletal radiologists, 6 podiatrists, 9 office-based sports

medicine physicians, 2 doctoral-level research staff and 10 basic science research staff members with secondary

appointments in our Orthopaedic Surgery Department.

The 2007 Outcomes book reflects our growing emphasis and effort to measure the functional outcome of a

wide range of surgical procedures and non-surgical treatments performed by the faculty in our Institute. This

publication reflects the surgical care of patient treated on the main campus and at our outpatient surgical centers

by the Orthopaedic Surgery Department. Our Rheumatology Department cares for patients with systemic

immunologic diseases resulting in vasculitis and inflammatory arthritis. We provide in this publication the

outcomes of care for these patients.

Our focus this year is on hip, knee and shoulder arthroplasty, and ACL and rotator cuff repair. This publication

reports, for these procedures, a minimum of one year follow-up. We have used validated functional outcome

tools that use patient reported data (SF-36, SF-12 PENN Shoulder Score and KOOS scores). We also report,

for many commonly performed procedures, the effect of patient-reported comorbidity on the severity of the

preoperative disability and the effect of these comorbidities on the short-term functional outcome after surgery.

We also report our patient satisfaction, length of stay and readmission data for several commonly performed

procedures. We have correlated these parameters of the treatment process with patient-reported comorbidity at

the time of index surgery.

Our Institute’s Center for Clinical Outcomes and Center for Vasculitis Research include 11 research staff and

4 part-time support staff. This group manages 31 prospective research projects, 52 clinical databases and 24

clinical trials in many areas of orthopaedic surgery and rheumatology. These centers are responsible for the

collection, management and analysis of the data presented in this year’s Outcomes book. Our staff will continue

to expand our department’s efforts in the next year to include clinical outcome data collection for other outpatient

and inpatient clinical care sites within the Cleveland Clinic health system. We also will add other database

registries for other subspecialty areas of orthopaedic surgery. We hope you find the 2007 publication informative

and of even greater value than the 2006 publication; and we look forward to your comments

and feedback.

Outcomes 2007 6

244,000

42,669

44

Orthopaedic Surgery visits in

2007

countries from which patients

were served by the Orthopaedic

and Rheumatologic Institute

Rheumatology visits in 2007

2007 Statistics

Number of Surgeries in 2007

Spine (Orthopaedic Department) 832

Lower Extremity 7,555

Upper Extremity 4,158

Other 746

Number of Upper Extremity Surgeries in 2007

Hand 756

Forearm 1,107

Humerus 508

Shoulder 1,787

Number of Lower Extremity Surgeries in 2007

Foot and Toes 805

Leg and Ankle Joint 631

Femur and Knee Joint 4,423

Pelvis and Hip Joint 1,696

Rheumatology Group Practice in 2007

Total Visits 42,669


Number of SurgeriesNumber of Surgeries

0

2,000

4,000

14,000

6,000

12,000

8,000

10,000

2003 2004 2005 2006 2007

Lower ExtremitySpine OtherUpper Extremity

Upper Extremity SurgeriesUpper Extremity Surgeries

0

5,000

1,000

2,000

3,000

4,000

2003 2004 2005 2006 2007

Forearm and Wrist Hand and Fingers

Shoulder Humerus and Elbow

Lower Extremity SurgeriesLower Extremity Surgeries

0

10,000

2,000

4,000

6,000

8,000

2003 2004 2005 2006 2007

Femur and Knee Joint

Foot and Toes

Pelvis and Hip Joint

Leg and Ankle Joint

Orthopaedic VolumesThe total number of surgeries, including upper and lower extremity surgeries, has steadily grown.

Outcomes 2007 8

Functional OutcomesFunctional outcomes were measured within the framework of three different registries: the mail-based Hip and Knee Registry started in 2001, the office/mail-based Shoulder Registry started in 2000 and the office-based OrthoMiDaS Registry started in 2006. The first two registries target midterm outcomes (one year and longer). The OrthoMiDaS Registry collects patient-reported outcomes when patients come to the office to see doctors; as such, it explores the functional status of various groups of patients, primarily during the early postoperative period (less than one year).

All registries are compatible. They capture sociodemographic characteristics, self-reported comorbidities and validated health-related general quality-of-life (HRQoL) SF36/12 (Short Form 36 and/or modified Short Form 12) instruments. The Shoulder Registry applies the validated Shoulder-Specific Questionnaire. All patients who visited the doctor’s office after March 2006 filled out a self-reported Musculoskeletal Review of Systems (MRoS) Questionnaire prior to seeing the doctor.

The 10 scores of the SF36/12 instruments reflect eight domains of general HRQoL and two composite scores. The eight domains are:

• Physical Functioning (PF)

• Role–Physical (RP)

• Bodily Pain (BP)

• General Health (GH)

• Vitality (VT)

• Social Functioning (SF)

• Role–Emotional (RE)

• Mental Health (MH)

The two composite scores are:

• Physical Health Composite Score (PCS)

• Mental Health Composite Score (MCS)

Both the SF36 and SF12 questionnaires were scored using normalized algorithms. The obtained scores have a mean value of 50 in the nonpatient population, and every 10 units correspond to one standard deviation from the norm. Values greater than 50 indicate better-than-average self-reported health, and values lower than 50 indicate worse-than-average self-reported health. Reference values of 50 are shown as horizontal yellow lines on all figures.

The Shoulder Questionnaire contains three domains:

• Function

• Pain

• Satisfaction

These domains produce one composite score:

• Total

9 Orthopaedic & Rheumatologic Institute

The Function scale contains 20 questions; its score ranges from 0 to 60. The Pain domain is measured with three questions; its score ranges from 0 to 30. The Satisfaction domain is represented by one question; its score ranges from 0 to 10. The sum of these three scores represents the Total shoulder-specific quality-of-life score, which ranges from 0 to 100. Higher scores correspond to better shoulder-specific quality of life.

Baseline information for the Shoulder Registry was collected in the office prior to patients seeing the doctor during their preoperative visit. Yearly postoperative follow-up information was collected either during the office visit or, for patients who did not come back for follow-up visits, via mail. The registry contains data on 1,057 patients operated on between 2000 and 2006 (1,159 surgeries) who met the inclusion criteria, completed baseline questionnaires and were eligible for follow-up data collection. A total of 1,083 surgeries were followed with at least one postsurgical questionnaire application (follow-up rate: 93 percent).

The Musculoskeletal Review of Systems Questionnaire contains eight visual analog scale (VAS) domains and produces six derivative scores.

The eight VAS domains pertain to:

• physical problems associated with the neck (Neck)

• physical problems associated with the left arm (Index Arm or Other Arm)

• physical problems associated with the right arm (Index Arm or Other Arm)

• physical problems associated with the left leg (Index Leg or Other Leg)

• physical problems associated with the right leg (Index Leg or Other Leg)

• physical problems associated with the spine (Spine)

• physical problems associated with other medical conditions (Other)

• emotional problems associated with musculoskeletal conditions (Emotion)

The six derivative scores pertain to:

• Index Arm

• Other Arm

• Index Leg

• Other Leg

• Arms (average of the Left Arm and Right Arm)

• Legs (average of the Left Leg and Right Leg)

The scores range from 1 to 10. Higher scores correspond to better quality of life.

Outcomes 2007 10

ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100

0-1 yrs 1-2 yrs 4+ yrsPre-op 2-4 yrs

ScoreScore

0

20

40

60

80

PF RP BP GH VT SF RE MH PCS MCS


Control

Total Shoulder Replacement for Primary OsteoarthritisA total of 144 patients completed the SF36/12 questionnaires and the validated shoulder-specific questionnaire at baseline and follow-up. All patients had primary osteoarthritis, and all had undergone a total shoulder arthroplasty. Their average age was 68.0 years (range: 38–89), and 55 percent were male.

Patients took approximately one year to complete their rehabilitation and reach their maximum level of improvement from surgery. Some 93 percent of patients had a successful surgical outcome, based on reaching or exceeding a minimum 15-point improvement over their preoperative Total score (the average preoperative Total score was 29 points). Some 79 percent of patients realized at least a 30-point improvement. The average postoperative Total score was 82 points. On average, the functional results were sustained over at least five years of follow-up.

The SF36/12 scores were generally less sensitive to changes associated with shoulder problems. They demonstrated that these patients on average were healthy and did not have any serious mental dysfunction. On average, these patients had normal scores for General Health (GH), Vitality (VT), Mental Health (MH) and Role-Emotional (RE), and a normal Mental Health Composite Score (MCS). Shoulder replacement did result in significant and sustained improvements in the Role-Physical (RP) and Bodily Pain (BP) scores and in the Physical Health Composite Score (PCS), all of which were low prior to surgery.

General Quality of Life (N = 144)

Shoulder-Specific Quality of Life (N = 133)

PF = Physical Functioning RP = Role-Physical BP = Bodily Pain GH = General Health VT = Vitality SF = Social Functioning RE = Role-Emotional MH = Mental Health PCS = Physical Component MCS = Mental Component


ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100

0-1 yrs 1-2 yrsPre-op 2-4 yrs

ScoreScore

0

20

40

60

80


Control


Humeral Resurfacing Hemiarthroplasty with and without Soft-Tissue Glenoid InterpositionA total of 32 patients with primary or secondary degenerative arthritis underwent humeral resurfacing (nonstemmed implant) without glenoid resurfacing or the use of soft-tissue glenoid resurfacing (glenoplasty). Indications for surgery were younger age and a high activity level. Patients’ average age was 43.5 years (range: 17–81), and 82 percent were male. Maximum follow-up was four years. The results were less favorable than those seen with standard total shoulder arthroplasty. The final functional recovery was slower, as some patients took more than a year to reach their maximum level of improvement. Some 85 percent of patients achieved a satisfactory outcome, and 67 percent had an improvement of more than 30 points in their Total scores; this compares with 93 percent and 79 percent, respectively, for patients who underwent standard total shoulder replacement. Also noted was an early trend toward deterioration in results over the first four years. This trend will require further study.

The difference between hemiarthroplasty with and without soft-tissue resurfacing of the glenoid will also require further study in a larger patient population. At no time after this type of surgery did the average patient satisfaction reach the level of patient satisfaction seen with standard total shoulder arthroplasty. The relative merit of hemiarthroplasty with or without soft-tissue interposition compared with standard total shoulder arthroplasty in the active patient younger than 50 years of age requires further study. The results presented for humeral resurfacing are very similar to our results with stemmed total shoulder replacement in older patients with osteoarthritis.




Outcomes 2007 12

ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Stemmed Hemiarthroplasty for Severe Osteoarthritis in Patients with an Intact Rotator CuffOlder patients with severe glenohumeral arthritis are on occasion candidates for hemiarthroplasty. In some cases, the rotator cuff is thin; in other cases, the loss of glenoid bone is severe, which makes the placement of a glenoid component difficult. The results of hemiarthroplasty in this series of patients (average age: 65.5 yr; range: 38-85; 64 percent male) were less favorable than those seen with total shoulder arthroplasty.





ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Shoulder Replacement for Rheumatoid ArthritisA total of 27 patients with rheumatoid arthritis and minimum one year follow-up were treated with either hemiarthroplasty or total shoulder arthroplasty between 2002 and 2006. The patients’ average age was 63.9 years (range: 28-83), and 27 percent were male. The shoulder scores were improved, reaching a maximum level of improvement between one and two years from surgery. Some 90 percent of patients reached the minimum threshold for successful surgery (a 15-point improvement in shoulder score); 69 percent had an improvement of more than 30 points. The severity and systemic nature of rheumatoid arthritis was reflected in the deterioration of results over the first five years after surgery. This is most likely due to persistent and new onset of rotator cuff pathology after shoulder replacement. The SF36/12 data for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP) and Physical Health Composite Score (PCS) reflected the same findings as those reflected in the shoulder score. This would suggest a deterioration in shoulder Function or overall deterioration in bodily Function associated with the systemic disease process.




Outcomes 2007 14

ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Hemiarthroplasty for Rotator Cuff Tear ArthropathyRotator cuff tear arthroplasty results in severe shoulder disability, which was reflected in the very low preoperative Total shoulder scores; scores for Physical Functioning (PF), Role-Physical (RP) and Bodily Pain (BP); and the Physical Health Composite Score (PCS) seen on the SF36/12. The patients in this series were older (average age: 69.9 years; range: 50–84), and 29 percent were male. They had lower-than-average General Health (GH), Vitality (VT) and Social Functioning (SF) scores as seen on the SF36/12. Of 31 patients with rotator cuff tear arthropathy who were operated on between 2001 and 2006, 82 percent had a satisfactory outcome as reflected by an improvement of at least 15 points in postoperative scores. However, only 50 percent had a better-than-30-point improvement over preoperative shoulder scores; the average postoperative score was 60 points. These results appeared to be sustained over the first five years after surgery.





ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Reverse Total Shoulder Arthroplasty for Rotator Cuff Tear ArthropathyReverse total shoulder arthroplasty has been performed at Cleveland Clinic since November 2003. Our early results with this prosthetic procedure in 43 patients with primary rotator cuff tear arthropathy are presented. The average age of these patients was 70.9 years (range: 35-88), and 41 percent were male. The SF36/12 data again demonstrated that this group had more comorbidities and lower Vitality (VT) and Social Functioning (SF) scores than did patients with osteoarthritis who were undergoing primary anatomic total shoulder replacement. Patients who underwent a reverse total shoulder replacement for primary rotator cuff tear arthropathy achieved an average postoperative score of 70 points, which was 10 points higher than the average score for hemiarthroplasty. Some 85 percent of patients had a significant improvement in postoperative Total score (15–30 points better than their preoperative score), and 64 percent of patients experienced an improvement of more than 30 points over their preoperative score. The superiority of the reverse total shoulder procedure over hemiarthroplasty was due almost entirely to improvements in the Function component of the shoulder score.




Outcomes 2007 16

ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Reverse Total Shoulder Arthroplasty for Failed Hemiarthroplasty To Treat Proximal Humeral FracturesA reverse total shoulder replacement for a failed hemiarthroplasty after failed surgery for a proximal humeral fracture presents a challenge that cannot be managed by anatomic prosthetics. Of the 21 patients in this series (average age: 66.1 years; range: 45–84; 42 percent male), five had infection requiring a two-stage revision. Remarkably, 89 percent of these patients were significantly (at least 15 points) improved after surgery; 47 percent had an improvement of more than 30 points. The results of the first three years’ experience with this procedure are encouraging.





ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Arthroscopic Rotator Cuff Repair for Full-Thickness Rotator Cuff TearsA total of 113 full-thickness rotator cuff tears (1-3 tendons) were repaired by arthroscopic means. The average age of the patients in this series was 58.9 years (range: 32-83), and 64 percent were male. Almost all of these patients had minimal or moderate tendon retraction (midhumeral head) and grade 2 or less muscle atrophy. The SF36/12 data showed that these patients had normal scores for General Health (GH), Vitality (VT), Social Functioning (SF) and Mental Health (MH), as well as a normal Mental Health Composite Score (MCS) prior to surgery. The results of arthroscopic repair were satisfactory or better in 88 percent of patients, with 74 percent achieving a greater-than-30-point improvement in their Total shoulder score. The average postoperative score was 87 points (preoperative average: 41).




Outcomes 2007 18

ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Open Rotator Cuff Repair for Full-Thickness Rotator Cuff TearsA total of 63 patients with large, chronic tears (grade 3 and 4 atrophy) and more than moderate retraction were indicated for open rotator cuff surgery. Their average age was 58.8 years (range: 16–82), and 80 percent were male. In cases where a tear was not reparable at the time of surgery or when preoperative magnetic resonance imaging (MRI) suggested an irreparable tear, a muscle transfer was considered for selected patients (younger, active patients with significant weakness). For older, less active patients with primarily pain-related problems whose preoperative MRI demonstrated an irreparable tear, a limited-goals arthroscopic surgery was considered. The average preoperative Total shoulder score was 41 points, and the average postoperative score was 80. Overall, 88 percent of patients were improved, and 64 percent achieved an increase of more than 30 points over their preoperative score. Their general good health preoperatively and the improvements in Function and Pain scores postoperatively were reflected in their SF36/12 scores.





ScoreScore

0

20

40

60

80

100

Function0-60

Pain0-30

Satisfaction0-10

Total0-100


ScoreScore

0

20

40

60

80


Control


Muscle Transfer for Irreparable Rotator Cuff TearsSelected patients with irreparable rotator cuff tears that involved the supraspinatus and infraspinatus rotator cuff were treated with transfer of the latissimus dorsi muscle — and in some cases with a transfer of the teres major. The average age of these patients was 57.0 years (range: 32–74), and 71 percent were male. The average Total score increased from 40 to 70 points postoperatively. It took patients more than one year to reach maximum levels of improvement. The difference between these muscle transfer patients and patients who underwent rotator cuff repair was reflected in the Function and Satisfaction scores. Although 75 percent of these patients achieved significant improvement with muscle transfer (a minimum increase of 15 points in the postoperative score), only 35 percent demonstrated an improvement of more than 30 points. These results clearly reflect the salvage and reconstructive nature of this procedure.




Outcomes 2007 20

ScoreScore

0

2

4

6

8

100-2 mo 2-12 moPre-op

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion

ScoreScore

0

20

40

60

80


0-2 mo 2-12 moPre-op 12-24 mo

Control

Total Hip ArthroplastyIn this series of patients who underwent total hip arthroplasty, the average age was 60.1 years (range: 20–90); 52 percent of patients were male. Preoperatively, patients demonstrated very low scores for the Index Leg (1.8 on the 10-unit scale) and some functional deficiency in the Other Leg and the Spine. During the first two months after surgery, a significant positive effect was observed in terms of scores for the Index Leg, Other Leg, Spine and Emotion. This effect continued to increase over time in the Index Leg (average improvement: 4.2 units) and was partially sustained in the Other Leg. General quality-of-life ratings also demonstrated small but significant improvements in Physical Functioning (PF), Role-Physical (RP) and Bodily Pain (BP) scores and in the Physical Health Composite Score (PCS). By the end of the second year, these scores had almost reached the level of scores observed in nonpatient populations (score 50).


Musculoskeletal Review of Systems (N = 252)



ScoreScore

0

2

4

6

8

10

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion


ScoreScore

0

20

40

60

80


0-2 mo 2-12 moPre-op 12-24 mo

Control

Revision of Total Hip Arthroplasty, Both ComponentsThe patients in this series, who had failed total hip arthroplasty, were treated with revision of the acetabular and femoral components. Their average age was 60.6 years (range: 32–84), and 49 percent were male. Improvement in the Index Leg during the first year after surgery was significant but modest (from 1.9 to 4.3 units on the 10-unit scale). It was accompanied by significant improvement in Emotion. All measured general quality-of-life domain scores were preoperatively lower than those in a control population. Scores for some of these domains — Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP) and Social Functioning (SF), as well as the Physical Health Composite Score (PCS) — steadily improved during the two years after surgery, but they remained lower than the control scores.




Outcomes 2007 22

ScoreScore

0

2

4

6

8

10

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion


ScoreScore

0

20

40

60

80


0-2 mo 2-12 moPre-op 12-24 mo

Control

Revision of Total Hip Arthroplasty, One ComponentThe average age of patients who had failed total hip arthroplasty and were treated with revision of the acetabular or femoral components was 61.9 years (range: 22-82); 50 percent of them were male. Improvement in the functional score of the Index Leg during the first year after surgery was modest (from 2.2 to 5.4 units on the 10-unit scale), but it was still greater than it had been after revision of both components. This improvement was accompanied by a significant improvement in the Emotion domain. Preoperatively, all measured general quality-of-life domains were lower than those of the control group. Some of them — Physical Functioning (PF), Role–Physical (RP) and Bodily Pain (BP), as well as the Physical Health Composite Score (PCS) — steadily improved during the two years after surgery, but they remained lower than the control scores.





ScoreScore

0

2

4

6

8

100-2 moPre-op

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion

ScoreScore

0

20

40

60

80


Control


Hip Arthroscopy with DebridementHip arthroscopy with debridement is a procedure of choice for acetabular labrum tears. The mean age of the patients in this series was 40.8 years (range: 18–68); 43 percent were male. Baseline score of the Index Leg was low (2.7 units on the 10-unit VAS). During the first two months after surgery, it had improved significantly (by 2.1 units). Functional improvement was followed by a small but significant improvement in the Emotion parameter. A lack of data does not allow us to draw any conclusions about the functional dynamics of the Index Leg after the first two months of observation. During the early recovery period, no improvement in general quality of life was observed. But by the end of the first year, improvements in several domains of general quality of life — as reflected by increases in scores for Physical Functioning (PF), Role-Physical (RP) and Bodily Pain (BP), as well as the Physical Health Composite Score (PCS) — were small but significant.




Outcomes 2007 24

ScoreScore

0

2

4

6

8

10

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion


ScoreScore

0

20

40

60

80


0-2 mo 2-12 moPre-op 12-24 mo

Control

Total Knee Arthroplasty, UnilateralIn this series of patients who underwent total knee arthroplasty, the average age was 63.9 years (range: 18-97); 35 percent of patients were male. The initially low Index Leg scores (2.1 units on the 10-unit scale) improved significantly during the early postoperative period and had reached a level of 6.0 by the end of the first year. Many of these patients had bilateral knee problems, as indicated by the low Other Leg score (6.3 units). Improvement in the preoperatively low scales of general quality of life was significant; the most prominent changes were observed during the first year.





ScoreScore

0

2

4

6

8

10

Neck Arms Legs Spine Other Emotion


ScoreScore

0

20

40

60

80


0-2 mo 2-12 moPre-op 12-24 mo

Control

Total Knee Arthroplasty, BilateralThe average age of patients who underwent total arthroplasty of both knees was 64.1 years (range: 48-82); 61 percent of these patients were male. In general, these patients were healthier than patients who had undergone unilateral knee arthroplasty; specifically, fewer of them had Neck, Arms and Spine problems. Preoperatively, the average score of both Legs (3.4 units on the 10-unit scale) was low, and this score did not improve significantly during the initial two months of postoperative evaluation. However, the Legs score did reach a level of 6.7 by the end of the first year. Improvement in the initially low domains of general quality of life was significant; the most prominent changes were observed during the first year, and improvement continued during the second postsurgical year.




Outcomes 2007 26

ScoreScore

0

2

4

6

8

10

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion


ScoreScore

0

20

40

60

80


0-2 mo 2-12 moPre-op 12-24 mo

Control

Revision of Total Knee ArthroplastyThis series involved patients who had failed primary knee arthroplasty. Their average age was 61.8 years (range: 35-86), and 45 percent were male. Preoperatively, their Index Leg scores were extremely low (1.6 units on the 10-unit scale). Patients had some dysfunction in the Other Leg (6.8 units), and their Emotion score was relatively low (5.4 units). Postoperative improvements in Index Leg and Emotion scores during the first year were statistically significant, although they were much less prominent than the improvements seen after their primary knee arthroplasty. General quality of life preoperatively was low in all measured domains; it improved significantly after the surgery, although it did not achieve the level of the nonpatient population during the first two postoperative years.





ScoreScore

0

2

4

6

8

10

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion


ScoreScore

0

20

40

60

80


Control


Anterior Cruciate Ligament ReconstructionAnterior cruciate ligament (ACL) insufficiency results in functional instability, and the knee can give way during cutting and pivoting activities. Instability can be corrected with ACL reconstruction. ACL reconstruction is performed with the patient’s own autograft hamstrings or patellar tendon or with an allograft tendon obtained from a tissue bank. In this series of ACL reconstructions, patients were younger than those in the other studied groups (average age: 31.7 years; range: 18-62); 60 percent were male. Except for the Index Leg, these patients were mostly healthy, as reflected by their scores related to Neck, Arms, Other Leg and Spine (all scores were close to 10). Preoperatively, patients demonstrated lower-than-normal scores for their Index Leg on the musculoskeletal review of systems and on the Physical Health Composite Score (PCS) of the SF36/12. During the first two months after surgery, these scores further decreased due to the postoperative limitations of function. However, they began to improve quickly after two months of recovery. Most patients were not expected to return to full activity until after six months.




Outcomes 2007 28

ScoreScore

0

2

4

6

8

10

Neck Arms IndexLeg

OtherLeg

Spine Other Emotion


ScoreScore

0

20

40

60

80


0-2 mo 2-12 moPre-op 12-24 mo

Control

Knee Arthroscopy with MeniscectomyMeniscus tears in the knee result in focal pain in the joint. The focal pain is accompanied by mechanical symptoms such as catching, locking and pain with twisting or pivoting. Knee arthroscopy with partial meniscectomy to remove the unstable injured meniscal tissue can alleviate these symptoms. Preoperatively, the patients in this series (average age: 54.3 years; range: 19-81; 40 percent male) had low Index Leg scores on the musculoskeletal review of systems. They demonstrated modest improvement in the Index Leg score during the first two months after surgery and no further improvement thereafter. Improvements in initially low domains of general quality of life were significant but small.





74%74% Loss of protectivesensation, but no presence of peripheral arterial disease

Loss of protectivesensation, but no presence of peripheral arterial disease

21%21% Loss of protectivesensation and presence of peripheral arterial disease

Loss of protectivesensation and presence of peripheral arterial disease

2%2% No loss of protective sensation, but presence of peripheral arterial disease

No loss of protective sensation, but presence of peripheral arterial disease

3%3% No loss of protective sensation and no presence of peripheral arterial disease

No loss of protective sensation and no presence of peripheral arterial disease

Healing Surgery

PercentPercent

0

40

60

80

100

20

1 2 3Months

4 50

Diabetic Foot UlcersFoot ulcer is one of the most common pathologies treated in the Diabetic Foot Clinic. A patient often comes to his or her initial visit with one or more ulcers that have been present for many months or even years. The Diabetic Foot Care Program has been tracking ulcer healing rates for patients who presented to Cleveland Clinic with ulcers in 2007. In the literature, a meta-analysis examining outcomes of neuropathic ulcers on the plantar aspect of the foot determined that 24.2 percent of ulcers were healed by three months (12 weeks), and 30.9 percent were healed by five months (20 weeks). In our Diabetic Foot Care Program, 52.7 percent of ulcers had healed by three months, and 68.1 percent had healed by five months (statistical analysis was performed with the time-to-event Cox model for competing risks). Standard treatment at Cleveland Clinic includes offloading (total contact cast, cast walker, half-shoe) and comprehensive wound care management, which incorporates newer wound treatment modalities. For some patients, ulcer healing is not possible without surgical intervention, which includes partial amputation or reconstructive surgery to correct any severe deformities that contribute to ulcer formation. In the presence of infection, a complete amputation may be necessary. With aggressive treatment and infection prevention, we have shown that better outcomes for diabetic foot ulcers are possible.

Time-to-Event Analysis of Diabetic Foot Ulcers Treatment

Patient Characteristics (N = 58)

Outcomes 2007 30

198198 DeformityDeformity

187187 Fracture/TraumaFracture/Trauma

123123 TumorTumor

118118 InfectionInfection

7171 OtherOther9898 Non-spineNon-spine

1,3171,317 DegenerativeDegenerative

559559 ArthrodesisArthrodesis

173173 VertebralAugmentationVertebralAugmentation

8686 Non-spineNon-spine

6767 TumorTumor

2626 DeformityDeformity

2626 Hardware InsertionHardware Insertion 151151 OtherOther

1313 BiopsyBiopsy

988988 DecompressiveDecompressive

2323 Hardware RemovalHardware Removal

Spine Problems (Neurological Institute)In 2007, we performed a total of 2,112 surgeries on 1,854 patients.

Procedural Mix

Diagnostic Mix


Change in Disease Activity and PR3–ANCA in 156 Patients with Wegener Granulomatosis

54 relapsed ¨ 116 sustained remission (>6 mos) Æ 62 remission continued

Ø

2 concurrent ANCA rise

9 ANCA rise within previous 12 mos

4 ANCA rise > 12 mos before relapse

31 no increase in ANCA

8 negative ANCA

Among 40 percent of all patients studied who had an increase in ANCA, relapse occurred within less than 1 year. Relapses often occur without a change in ANCA or with negative ANCA values. PR3–ANCA titer changes do not predict disease relapse in Wegener granulomatosis.

Conclusion: Relapses often occur without a change in ANCA or with negative ANCA values.

Antiproteinase 3 Antineutrophil Cytoplasmic Antibodies and Disease Activity in Wegener GranulomatosisFinkielman JD, Merkel PA, Schroeder D, Hoffman GS, Spiera R, St Clair EW, Davis JC Jr, McCune WJ, Lears AK, Ytterberg SR, Hummel AM, Viss MA, Peikert T, Stone JH, Specks U; WGET Research Group. Antiproteinase 3 antineutrophil cytoplasmic antibodies and disease activity in Wegener granulomatosis. Ann Intern Med. 2007;147(9): 611–9.

The utility of antineutrophil cytoplasmic antibody (ANCA) levels to guide the management of patients with Wegener granulomatosis remains controversial. The goal of this study was to determine whether decreases in proteinase 3 (PR3)–ANCA levels are associated with shorter time to remission and whether increases are followed by relapse. This issue was felt to be of great clinical significance because clinicians in practice often use change in titers of these antibodies as a reliable guide to treatment decision-making.

In collaboration with investigators in the Wegener’s Granulomatosis Etanercept Trial (WGET) Research Group, change in titers of PR3–ANCA and disease activity and probability of relapse were analyzed. The study was prospective and included eight United States medical centers that were participating in a treatment trial for Wegener granulomatosis.

One hundred fifty-six patients with Wegener granulomatosis enrolled during periods of active disease. The PR3–ANCA levels were only weakly associated with disease activity. Changes in PR3–ANCA levels explained less than 10 percent of the variation in disease activity. Increases in PR3–ANCA levels were not associated with relapse. Decreases in PR3–ANCA levels were not associated with shorter time to remission.

These findings suggest that PR3–ANCA levels cannot be used to guide immunosuppressive therapy. We expect these results to modify physician behaviors in the use of ANCA as a prognostic tool.

Rheumatology

Outcomes 2007 32

Mean BMD Change (g/cm2)Mean BMD Change (g/cm2)

0.00

0.40

0.20

0.60

0.80

0.10

0.12BP* NaïvePrevious BP*

Lumbar Spine

P=0.31

P=0.86 P=0.81

Total Hip Femoral Neck

Bone Mineral Density Response to Teriparatide in Treatment-Naïve Patients and Patients Previously Treated with a BisphosphonateElizabeth A. File, MD, and Chad Deal, MD

rh PTH 1-34 (teriparatide) (TPTD) is approved for the treatment of patients at high risk for fracture. Pretreatment with a bisphosphonate has been shown to blunt the bone mineral density (BMD) response to TPTD in some but not all studies. This study evaluated whether previous exposure to a bisphosphonate would blunt the skeletal response to TPTD.

A retrospective analysis of patients given a prescription for TPTD at Cleveland Clinic from January 2003 to July 2006 was performed. Patients were stratified into two TPTD treatment arms: bisphosphonate-naïve patients and those previously treated with a bisphosphonate. The primary outcomes were the absolute changes in lumbar spine, total hip and femoral neck BMD after ≥ 12 months of TPTD therapy. Secondary outcomes included the percentage change in markers of bone turnover (urinary N-telopeptide of type I collagen [NTX]), osteocalcin and alkaline phosphatase). We evaluated the percentage of patients who developed significant hypercalcemia, defined as a calcium level ≥ 11.0 mg/dL on one occasion or > 10.5 mg/dL on two or more occasions.

The cohort included 96 Cleveland Clinic patients, 66 of whom met the criteria for the primary outcome analysis. Inclusion criteria were the following: BMD measurement < 12 months prior to initiation of TPTD, a follow-up BMD measurement after ≥ 12 months of therapy with TPTD, and the availability of bone turnover markers drawn before and after initiation of TPTD therapy. Thirty patients were bisphosphonate-naïve, and 36 patients had received a bisphosphonate prior to initiation of TPTD.

There was no significant difference between the two groups in the mean absolute change in the lumbar spine, total hip or femoral neck BMD after ≥ 12 months of therapy with TPTD. Both treatment arms had significant increases in NTX and osteocalcin with no significant difference in the percentage change of response. In the entire cohort, significant hypercalcemia occurred in 20 of 96 patients (21 percent) receiving TPTD. Patients with hypercalcemia had a higher mean baseline calcium level (10.0 vs. 9.6 mg/dL). Only 1 patient (< 1 percent) discontinued TPTD due to hypercalcemia.

In our cohort, previous exposure to a bisphosphonate did not blunt the anabolic effect of TPTD. There was no significant difference in the percentage change in bone turnover markers in the two groups. Calcium elevations were frequent in patients on TPTD, but discontinuation of therapy was rare.

Absolute Change in BMD after ≥ 12 Months of Therapy with Teriparatide

Wilcoxon Two-Sample Test

* Bisphosphonate

Dr. Chad Dealwas appointed to the

board of directors of

the American College of

Rheumatology in 2008


Patients (Percent)Patients (Percent)

0

20

40

60

80

100

2000 2005 2006 2007

Dual-Energy X-ray Absorptiometry Performance in Women Older than 65 YearsOsteoporosis is a major public health issue. Current quality measures by HEDIS (Healthcare Effectiveness Data and Information Set) require measurement of bone density and/or therapy in women with fracture. In order to reduce the burden of osteoporosis-related morbidity and mortality, organizations including the NOF (National Osteoporosis Foundation), ISCD (International Society for Clinical Densitometry) and the U.S. Preventive Services Task Force have recommended bone density measurement for women older than 65 years.

Since 2000, Cleveland Clinic’s Center for Osteoporosis and Metabolic Bone Disease and our Regional Medical Practice Osteoporosis Program have developed programs to increase the use of bone density measurements in women older than 65 years. Educational programs for primary care physicians and non-physician clinicians were begun in 2000. In 2003, a best-practice alert was instituted that resulted in a pop-up reminder in the electronic medical record at the patient visit if dual-energy X-ray absorptiometry (DEXA) had not been performed. The alert allows the healthcare provider to order a DEXA scan or record whether the patient has had a DEXA scan outside Cleveland Clinic. Patients who were offered DEXA but refused were excluded from the analysis.

In 2000, only 33 percent of women older than 65 years had DEXA performed. Compliance continues to improve. The percentage of women who had DEXA has risen from 33 percent to 88 percent.

Increases in the Percentage of Women Aged ≥ 65 Years Who Underwent Dual-Energy X-ray Absorptiometry Since 2000

Outcomes 2007 34

Persistent Hematuria in Patients with Wegener Granulomatosis: Renal Injury and Incomplete Repair or Active Disease Following Apparent Induction of Remission?Marina Magrey, MD, Tiffany Marie Clark, CNP, Alexandra Villa-Forte, MD, MPH, and Gary S. Hoffman, MD, MS

Background: Wegener granulomatosis (WG) is a systemic disease that is often associated with an immune-mediated form of glomerulonephritis (GN). Renal disease most often manifests as microscopic hematuria with or without red blood cell (RBC) or mixed cellular casts, proteinuria, and an elevated serum creatinine concentration.

Objective: To determine whether persistent hematuria, in the setting of apparent clinical remission, may reflect glomerular injury and not active renal disease.

Methods: Analysis of data from 82 patients with new-onset WG, of whom 25 had GN at presentation.

Results: Twenty of 25 patients with GN achieved sustained remissions (> 6 consecutive months duration). During initial periods of active disease, the median peak serum creatinine was 1.9 mg/dL (range: 0.6–13.6). The median time to remission was 4 months (range: 2-13). After effective therapy, median creatinine was 1.1 mg/dL (range: 0.4–1.8). Ten of 20 patients had prolonged hematuria over a period of > 6 months. Within this subset, five subsequently normalized urine over a median period of 11 months and five did not achieve normal urine over a median follow-up period of 38 months. Thus, 10 of 25 patients with WG and GN had sustained hematuria in spite of apparent prolonged clinical remission.

Conclusion: Patients with WG and GN may achieve enduring remissions that allow for withdrawal of medications in spite of continued microscopic hematuria with or without RBC casts for months or even years. Continued use of aggressive immunosuppressive therapies in such patients would be ill-advised and could lead to irreversible and even life-threatening side effects from cyclophosphamide or high-dose corticosteroids.

82 patients w/new-onset WG

25 with GN

5 remission < 6 months

10 sustained remission and chronic hematuria

over > 6 months

5 continued hematuria for a median of 38 months

5 cleared hematuria in a median of 11 months

20 sustained remission > 6 consecutive months


Patients (N=46)Patients (N=46)

0

10

20

30

40

50

New InfusionStarts

PPD Performedand Negative

PPD OutsideCCF

BiologicStopped

Purified Protein Derivative Using the Mantoux MethodBiologic therapies have been used since 1998 for the treatment of patients with rheumatoid arthritis and other inflammatory arthritis (psoriatic arthritis and ankylosing spondylitis). A variety of agents — including tumor necrosis factor inhibitors, interleukin 1 inhibitors, T-cell modulators and B-cell-specific agents — have come into clinical use. Successful use of these agents requires careful monitoring of both efficacy and toxicity. Patients treated with these agents have an increased risk for infection. The increased risk for active tuberculosis is in most instances a result of reactivation of latent infection in patients treated with these agents. While no definitive guidelines exist for pretreatment evaluation for latent tuberculosis, most experts agree that a purified protein derivative (PPD) using the Mantoux method for skin testing should be performed. A negative PPD test should be verified prior to institution of these therapies.

Clinicians working in Cleveland Clinic’s Department of Rheumatic and Immunologic Diseases (Orthopaedic and Rheumatologic Institute) have established a new quality initiative that involves PPD skin testing. As of 2007, a PPD skin test is required for all eligible patients who are started on a biologic infusion. Clinicians are now required to document a negative PPD skin test prior to the initiation of biologic infusions or are required to indicate a valid reason why PPD skin testing was not performed. In 2007, biologic infusions were indicated for 46 patients. Ninety-eight percent (45/46) of those started on infliximab, abatacept, anakinra or rituxan at Cleveland Clinic had documentation of a negative PPD test in 2007 prior to initiation of the infusion (three of those patients had a documented negative PPD test from a physician in the surrounding community). In the case of the one remaining patient without documentation of a negative PPD skin test, the biologic infusion was initiated but stopped for other reasons.

PPD Screening in Patients Started on Biologic Therapies in 2007 at Cleveland Clinic

Outcomes 2007 36


0

20

40

60

80

100

Total DiseaseRemissions

Sustained DiseaseRemissions >6 months

Prognosis of American Patients with Takayasu ArteritisKathleen Maksimowicz-McKinnon, DO, Tiffany Marie Clark, CNP, and Gary S. Hoffman, MD, MS

Takayasu arteritis (TAK) is a granulomatous vasculitis of unknown etiology that affects the aorta, its major branches and the pulmonary arteries. The outcomes of patients with TAK — including clinical, laboratory and radiographic manifestations — were assessed. We evaluated the response to interventions, remission and relapse rates and disease progression of TAK in an American cohort and compared these observations to cohorts from the United States, Japan, India, Italy and Mexico.

Seventy-five patients followed at Cleveland Clinic’s Center for Vasculitis Care and Research were retrospectively studied using a uniform database that included clinical, laboratory and imaging data. Vascular imaging studies were performed at least yearly to monitor disease progression. The median age at onset was 26 years. Ninety-two percent of patients were Caucasian and 89 percent were female. Median duration of follow-up was 3.0 years.

Common manifestations at disease onset included loss or asymmetry of pulse (57 percent), limb blood pressure discrepancy (53 percent) and bruits (53 percent). Eleven percent of patients were asymptomatic prior to disease diagnosis. Initial angiographic studies demonstrated aortic abnormalities in 79 percent of patients and frequent involvement of the subclavian (65 percent) and carotid (43 percent) arteries.

Ninety-three percent of longitudinally followed patients attained disease remission of any duration, but only 28 percent sustained remission of at least 6 months’ duration after prednisone was tapered to less than 10 mg/dL. Both angioplasty and vascular surgery procedures were initially successful, but recurrent stenosis occurred in 78 percent of angioplasty and 36 percent of bypass/reconstruction procedures. More than two-thirds of patients were impaired in carrying out routine daily activities, and approximately one-quarter of all patients were occupationally disabled.

Disease manifestations in our cohort were similar to the NIH, Italian, Japanese and Mexican cohorts in female predominance and disease manifestations but differed from the Indian cohort in that the latter group had a higher frequency of males, abdominal aorta and renal artery involvement, and hypertension.

While symptomatic improvement usually follows glucocorticosteroid therapy, relapses usually occur in TAK with dose reduction. Attempts to restore vascular patency are often initially successful, but restenosis occurs frequently. Chronic morbidity and disability occur in most patients with TAK in the U.S. This concept is not widely appreciated in the U.S. and other Western countries.

Disease Remission in Patients with Takayasu Arteritis



0

20

40

60

80

Following Angioplasty Following Bypass/Reconstruction


0

40

20

60

80

100

AnyDisability

PartialDisability

CompleteOccupational

Disablity

Mortality

Recurrent Stenosis following Angioplasty and Vascular Surgery

Disability and Mortality in Takayasu Arteritis

Dr. Carol Langford

Dr. Carol Langford

was awarded a 2-year,

$100,000 pilot project

grant from the Rare

Diseases Clinical Research

Network (RDCRN),

National Institutes of

Health. This grant

supports mechanistic

and biomarker analyses

in conjunction with the

RDCRN-sponsored trial

examining abatacept

(CTLA4-Ig) in mild

relapsing Wegener

granulomatosis.

was awarded a 5-year,

$3.8 million contract

award to conduct

concurrent pilot studies

in giant cell arteritis

and Takayasu arteritis

to examine the safety,

efficacy, and immunologic

effects of abatacept in

large-vessel vasculitis

from the National

Institute of Arthritis and

Musculoskeletal and

Skin Diseases, National

Institutes of Health.

Outcomes 2007 38

Proportion of Patients (Percent)Proportion of Patients (Percent)

0

40

20

60

80

100

PlaceboN=8/16

P=0.651

Infliximab 5mg/kg

N=12/28

Efficacy of Infliximab, an Anti-Tumor Necrosis Factor-a Agent, in Giant Cell Arteritis (GCA).Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, Salvarani C, Xu W, Visvanathan S, Rahman MU, for the Infliximab-GCA Study Group. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: A placebo-controlled randomized trial. Ann Intern Med. 2007; 146: 621-30.

Giant cell arteritis is an inflammatory vasculopathy affecting large and medium-sized arteries. Glucocorticoids are highly effective in GCA treatment but smoldering disease activity may persist for years. Additional immunosuppressive treatments as steroid-sparing agents have been considered for treatment. This trial was designed to evaluate the efficacy of infliximab, an anti-tumor necrosis factor-a agent, in giant cell arteritis (GCA).

The trial design was a randomized, double-blind controlled trial at the Cleveland Clinic and 22 sites in the United States, the United Kingdom, Belgium, Italy, and Spain. Forty-four patients with newly diagnosed GCA that was in glucocorticosteroid-induced remission were randomly assigned to receive infliximab or placebo.

Primary end points were the number of patients who remained free of relapse through week 22. These end points were measured through week 22, when an interim analysis was done that resulted in early discontinuation of the planned 54-week trial. Infliximab therapy did not increase the proportion of patients without relapse at week 22 compared with placebo, nor did it increase the proportion of patients whose glucocorticosteroid dosages were tapered to 10 mg/dL without relapse.

This trial provides evidence that using infliximab as maintenance therapy in patients in glucocorticoid-induced remission of newly diagnosed giant cell arteritis is of no benefit and may be harmful. This study was the first randomized, placebo-controlled, double-blind, multicenter trial of standardized treatment with glucocorticosteroids and adjunctive treatment with placebo or infliximab in patients with newly diagnosed giant cell arteritis. The results should result in caution about the use of such therapy, which intuitively appeared to be quite rational, but in fact was of no benefit.

Proportion of Relapse-Free Subjects through Week 22

Primary endpoint includes relapses, nl ESR, symptoms and increase pred


Percentage of Normothermic PatientsPercentage of Normothermic Patients

0

10

20

30

40

50

60

1st Qrt 2007N = 377

3rd Qrt 2007N = 372

4th Qrt 2007N = 408

2nd Qrt 2007N = 382

PercentagePercentage

0

20

40

60

80

100

2006N = 377

2007N = 107

The Section of Anesthesia for Orthopedic Surgery continues its emphasis on the management of perioperative normothermia (≥36.0˚C). Although the trend in 2007 was neutral, the addition of this measure in early 2008 to the Anesthesiologist Dashboard clinical practice reporting tool for staff anesthesiologists will provide data for continuous improvement.

The Department of General Anesthesiology visits total joint replacement inpatients on their second postoperative day to evaluate the early postoperative period and to obtain patients’ responses to a standardized anesthesia experience survey. One of the questions patients are asked is how much they agree or disagree with the following statement: “I threw up or felt like throwing up.” The chart below shows the percentages of patients who disagreed with that statement. Results for 2006-2007 are shown below.

Perioperative Normothermia

Management of Postoperative Nausea and Vomiting

Anesthesiology

Outcomes 2007 40

PercentagePercentage

0

20

40

60

80

100

2006N = 729

2007N = 1069

Another question in the postoperative patient satisfaction survey asks for a response to the statement, “I was satisfied with my anesthesia care.” The chart below shows the percentages of patients who agreed with that statement. Results for 2006 and 2007 are shown below.

Satisfaction with Anesthesia Services


Surgical Quality ImprovementSurgical Care Improvement Program (SCIP)SCIP is a national campaign aimed at reducing surgical complications by 25 percent by the year 2010. SCIP is sponsored by the Centers for Medicare and Medicaid Services (CMS) in collaboration with a number of other national partners serving on the steering committee, including the American Hospital Association (AHA), Centers for Disease Control and Prevention (CDC), Institute for Healthcare Improvement (IHI), The Joint Commission and others. Cleveland Clinic is committed to improving the care of surgical patients and participates in SCIP. A multidisciplinary team including the Surgery Institute, Anesthesiology Institute, Infectious Disease Department, Nursing Institute, and Quality and Patient Safety Institute works together to ensure that our surgical patients receive appropriate care.

Percent

0

20

100

40

60

80

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Cleveland ClinicNational Average*Top Hospitals*


Percent

0

20

100

40

60

80


Appropriate Preoperative Prophylactic Antibiotic Timing 2007

Appropriate Prophylactic Antibiotic Selection 2007

* Source: United States Department of Health and Human Services, Hospital Compare Most current reported discharges July 2006 to June 2007. “Top Hospitals” represent the top 10 percent of reporting hospitals nationwide. National average of all reporting hospitals in the United States.


Outcomes 2007 42


Percent

0

20

100

40

60

80



Percent

0

20

100

40

60

80


Prophylactic Antibiotics Discontinued within 24 Hours After Surgery 2007

Recommended Venous Thromboembolism Prophylaxis Received by Patient 2007


* Source: United States Department of Health and Human Services, Hospital Compare Most current reported discharges January 2007 to June 2007. “Top Hospitals” represent the top 10 percent of reporting hospitals nationwide. National average of all reporting hospitals in the United States.


Recommended Venous Thromboembolism Prophylaxis Ordered 2007



Percent

0

20

100

40

60

80

* Source: United States Department of Health and Human Services, Hospital Compare Most current reported discharges January 2007 to June 2007. “Top Hospitals” represent the top 10% of reporting hospitals nationwide. National average of all reporting hospitals in the United States.

Outcomes 2007 44


Percent

0

20

100

40

60

80

Cleveland Clinic*

Surgery Patients Who Received their Beta Blocker Perioperatively

* No national benchmark data available at this time


Excellent

PercentPercent

0

100

80

60

40

20

Very Good Good Fair Poor

N=4114

Excellent

PercentPercent

0

100

80

60

40

20

Very Good Good Fair Poor

N=4111

ExtremelyLikely

PercentPercent

0

100

80

60

40

20

VeryLikely

SomewhatLikely

SomewhatUnlikely

VeryUnlikely

N=3990

Overall Rating of Care 2007

Overall Rating of Provider Care 2007

Would Recommend Provider 2007

Outpatient - Orthopaedics and Rheumatology InstituteWe ask our patients about their experiences and satisfaction with the services provided by our staff. Although our patients are already indicating we provide excellent care, we are committed to continuous improvement.

Patient Experience

Outcomes 2007 46

0

20

40

60

100

Cleveland Clinic

Total Cleveland Clinic Survey Respondents = 4,725

HCAHPS National Average

Percent “9” or “10”Percent “9” or “10”

80

0

20

40

60

100

Cleveland Clinic HCAHPS National Average

Percent “Yes, definitely”Percent “Yes, definitely”

80

Total Cleveland Clinic Survey Respondents = 4,725

Overall Rating of Care (0 worst - 10 best scale) October 2006 - June 2007

Would Recommend Facility October 2006 - June 2007

Inpatient - Cleveland ClinicWith the support of the Center for Medicare and Medicaid Services (CMS) and its partner organizations, the first national standard patient experience survey was implemented in late 2006. Adult medical, surgical, and obstetrics and gynecology patients treated at acute care hospitals across the country are included in the survey. Results collected for initial public reporting, published on www.hospitalcompare.gov in March 2008, are shown here.


Innovations

Distance Walked (feet)Distance Walked (feet)

Rapid RecoveryTraditional

0

80

60

40

20

100

POD #0 POD #1Post-Operative Day

POD #2 POD #3

Rapid Recovery Standing andambulation

Bed restDangling atedge of bed

Ambulation andPhysical Therapy

BID

Anticipated discharge to

rehab facility orhome

Ambulation andPhysical Therapy

BID

Anticipateddischarge

home

Traditional

Day of Surgery Post-op Day 1 Post-op Day 2 Post-op Day 3 Post-op Day 4

Cleveland Clinic Program Shortens Recovery After Total Hip Replacement As the demand for hip replacement surgery expands, Cleveland Clinic’s Department of Orthopaedic Surgery within the Orthopaedic and Rheumatologic Institute is at the forefront of the development of new multimodal approaches to improving patient outcomes and overall satisfaction. For many patients, satisfaction means a quicker discharge home and an accelerated return to daily routine. With this in mind, our postoperative care has focused on reducing pain and increasing their function at the time of discharge. Our Rapid Recovery (RR) program, initiated in 2006, is a collaborative effort between orthopaedic surgery, anesthesia acute pain management, physical therapy and nursing services. The goals of this program are to minimize immediate postoperative pain and emphasize early and frequent mobilization as a means of achieving these goals.

In addition to patient satisfaction, several other factors are prompting our efforts. Traditionally, patients were kept in the hospital for an average of four days after joint replacement surgery, and were then transferred to an inpatient rehabilitation center for 10 to 14 days. The current health care climate encourages an early discharge directly home when appropriate. Demographic data tell us that overall, patients receiving total joint replacements are younger and more active — and less willing or able to spend an extended period in convalescence. Additionally, third-party payors are becoming more selective in approving patients for inpatient rehabilitation stays.

With Cleveland Clinic’s Rapid Recovery program, the goal is to reduce pain and improve patient function as measured by meeting certain milestones earlier. Secondarily, we found that most patients benefited from a safe discharge home by postoperative day two or three (Figure 1). There is no anticipated subsequent inpatient rehabilitation; instead, patients undergo their initial physical therapy at home. Inclusion criteria were the same for patients in both groups.

Once it has been determined that the patient is hemodynamically stable and possesses the necessary strength, he or she stands and is assisted in ambulation to tolerance. Beginning on postoperative day one, the patient is seen twice a day for therapeutic range-of-motion and ambulation. We found that most patients can be safely discharged home by postoperative day two or three. After the initial period of home physical therapy, they are transitioned to an outpatient facility to continue rehabilitation.

Results indicate that by undergoing a RR protocol following a hip replacement, patients ambulate further, experience less pain, spend less time in the hospital and are discharged home vs. to a rehab facility at an increased frequency as compared with those in the traditional protocol.

The dedicated staff of the RR program includes three surgeons, five physical therapists and two case managers who work closely to optimize the entire experience. Because patients are hospitalized for such a short time, effective communication is essential between members of the healthcare team, the patient and his or her family to prepare properly for discharge.

Figure 1. A timeline comparing traditional and rapid recovery postoperative physical therapy pathways

Averaged Distance Walked

Outcomes 2007 48

Number of days

the average hip

replacement patient

spent in the hospital

and step-down unit

through our “Rapid

Recovery Program”

3.5

Rapid Recovery Traditional Protocol

Length of Stay Avg in days (SD) 3.5 (1.3) 4.4 (2.0)

DISCHARGE DISPOSITION: Home 72.4% N=21 53.8% N=35 Rehabilitation Facility 27.6% N=8 46.2% N=30

DISTANCE AMBULATED (feet) POD#0 27.6 NOT TESTED POD#1 74.3 27.9 POD#2 81.1 44.7 POD#3 94.5 67.3

PAIN POD#0 3.8 NOT TESTED POD#1 4.5 4.6 POD#2 1.4 4.6 POD#3 2.4 3.9


TraditionalFNC

PACUdischarge

Before PTDay 1

After PTDay 1

Before PTDay 1

After PTDay 1

HospitalStay

88

Average PainAverage Pain

66

44

22

00In PACU

TraditionalFNC

Knee Society Score

%

Knee Society Function

100100

8080

6060

4040

2020

00

Managing Perioperative Pain after Total Knee Replacement

Wael Barsoum, MD, Mark Froimson, MD, Loran-Mounir Soliman, MD, George Muschler, MD, Victor Krebs, MD, Alison Klika, Mike Dombrowski, PA-C, and Dept. of Physical Medicine and Rehabilitation

The main goals for any joint replacement procedure are to relieve pain and restore function, allowing patients to improve their overall quality of life and remain as independent as possible. Improved surgical techniques (such as minimally invasive total knee arthroplasty), procedures and pain management allow for earlier and more aggressive rehabilitation following surgery.

At Cleveland Clinic, revolutionary new pain management protocols have been instituted in total knee replacement patients. The protocols aim to decrease pain and improve function in the short term for patients. All patients who undergo a unilateral primary knee replacement are eligible for the “Pain-Free Knee” program. For patients undergoing knee replacement, pain control is improved by the use of a femoral nerve catheter that stays in place for the first 24 to 48 hours. To facilitate a quicker resolution of motor and sensory block, surgeons administer shorter-acting spinal anesthetics prior to surgery. At the conclusion of each surgery, the tissues surrounding the joint are injected with an analgesic cocktail to provide enhanced early pain relief. As soon as the spinal block has worn off (after about two hours), a physical therapist performs a thorough evaluation, which focuses on assessing the strength of the operative joint as well as the contralateral joint and the upper extremities.

We are pleased to report that our data using this new pain protocol has led to patients having significantly less pain on each day of their hospitalization and improved function scores up to four weeks after surgery. Given the historical belief that knee replacement is one of the most painful interventions we perform, these data are remarkably promising. In addition, this program has allowed patients to be discharged more commonly directly home, and significantly more quickly. Specifically looking at Dr. Barsoum’s patients, there has been a 1.4-day decrease in length of stay for patients with the “Pain-Free Knee Program” compared with the traditional protocol.

FNC = Femoral Nerve Catheter

Outcomes 2007 50

ScoreScore

0

20

40

60

80

100

PreopAverage IKDC (months)

1 3 6 9 1 year

Clinical Trials in Tissue Engineering of Connective TissuesProsthetic joint replacement has been extremely successful in the older patient with more diffuse disease and joint deformity. Local arthritic lesions and focal traumatic cartilage loss has been difficult to treat, particularly in the young and active patient. In these lesions, joint preservation is preferred over prosthetic replacement. Arthroscopic debridement and microfracture have had limited success because the local tissues have a limited capacity to regenerate a functional articular cartilage. Several tissue engineering strategies have recently been proposed using autologous articular chondrocytes in suspension placed under an autologous periosteal flap of soft tissue sewn over the debrided articular cartilage defect. There has also been limited success with this treatment paradigm. Difficulties with this treatment relate to traumatic injury to the surrounding intact articular cartilage secondary to sewing the soft tissue flap, leaking of the cell suspension from the created compartment, overgrowth of the periosteal flap and incomplete incorporation of the cartilage regenerate with the surrounding intact articular cartilage.

The Department of Orthopaedic Surgery at the Cleveland Clinic (Drs. Iannotti, Parker and Miniaci) conducted the first and only phase I FDA clinical trial using a purified xenograft type I collagen matrix with embedded autologous articular chondrocytes cultured over a 10-to-14 day period to develop a tissue engineered articular cartilage substitute. This cultured gel-like material was implanted, at a second-stage surgery, into the debrided articular cartilage defect through a minimally invasive arthrotomy. One set of punches creates a precise and regular defect in the area of the damaged cartilage and a slightly larger graft material is press fit and adhered to the bone bed of the defect using a fibrin glue. This study was conducted on 10 patients and has been followed for > than 1 year, with 3-month interval outcomes evaluations, a 1-year post-implant arthroscopic second look and biopsy, and MRI at 1 month and 1 year postoperatively. Through collaboration with the Section of Musculoskeletal Radiology (Dr. Carl Winalski), Lerner Research Institute (Dr. Cahir McDevitt) and the Department of Pathology (Dr. Thomas Bauer), a thorough assessment of the cartilage implant was carried out at the 1-year evaluation and arthroscopic biopsy.

The average International Knee Documentation Committee (IKDC) validated outcomes score was 34 preoperatively, 21 at one month postoperatively, 46 at three months postoperatively, 52 at 6 months postoperatively, 61 at 9 months and 64 at 1 year. (Figure 1)

Excellent correlation between the IKDC score improvement, MRI follow-up, arthroscopic and histologic appearance is exemplified by one patient. His 1-year postoperative IKDC score was 94 with a profile of 61 preoperatively, 24 at 3 months, 67 at 6 months, and 82 at 9 months. His 1-year follow-up MRI revealed excellent fill and loss of subchondral edema (Figure 2), arthroscopy revealed excellent appearance of the articular cartilage (Figure 3) and the histology revealed “hyaline-like tissue” (Figure 4).

Figure 1


Figure 2 Figure 3

Figure 4

Outcomes 2007 52

Preventive Cardiology ReferralsPreventive Cardiology Referrals

0

20

40

60

80

100

2004-2005 2006 2007

Dr. Elaine Husniwas awarded a 2-year,

$180,000 Clinical

Investigator Fellowship

Award from the American

College of Rheumatology

Research and Education

Fund. This award

supports investigation

of atherosclerosis in

rheumatoid arthritis.

Impact of Electronic Alerts on Preventative Cardiology Services for Patients with Systemic Rheumatic Disease: Implications for Patient CareM. Elaine Husni, MD, MPH, Gary Hoffman, MD, Julie Huang, MD, and Stan Hazen, MD, PhD

Despite the known significant cardiovascular risk in patients with rheumatic disease, there is low utilization of preventive cardiology services. An automatic clinician alert system was implemented via the electronic medical record in June 2006. Any patient with a diagnosis of a systemic rheumatic disease seen in the Cleveland Clinic Department of Rheumatic and Immunologic Diseases triggered a “pop-up” alert recommending referral to Preventive Cardiology for cardiovascular risk assessment. The Section of Preventive Cardiology PreCIS® database was then queried using SAS data retrieval for a monthly report of patients referred from Rheumatology or for a diagnosis of autoimmune disease. Prior to this best practice clinical alert system, additional before/after interventions were also examined to see which modalities had the highest impact for increasing referrals to Preventative Cardiology for this high-risk group. These interventions included direct clinician-to-clinician interactions, academic grand rounds conferences, research seminars and staff meeting announcements devoted to the cardiovascular risk in systemic rheumatic diseases.

The highest impact was seen with the use of best practice clinical alert. Prior to implementation of the “pop-up” alerts, a total of 16 patients over 15 months were evaluated. The monthly average referral rate increased from 1.07 patients to 12.5 patients per month. The majority of these patients required some cardiac risk intervention, including initiation of statin therapy for dyslipidemia, electrocardiogram and/or non-invasive cardiac testing for suspicion of coronary artery disease.

Use of a best practice clinician alert system is a highly effective means of increasing referral

of patients with systemic rheumatic diseases to preventive cardiology. Further research will

be needed to determine whether adoption of similar best practice clinical alerts will result in

reduced cardiovascular burden in this high-risk group.


Dr. Gary Hoffman was reappointed to the FDA

Advisory Panel for Arthritis

drugs. He is editor of Current

Opinion in Rheumatology.

Antiplatelet and Anticoagulant Therapy in Patients with Giant Cell Arteritis Michael S. Lee, Scott D. Smith, Anat Galor, and Gary S. Hoffman

A study completed by the combined team of ophthalmologists and rheumatologists in the Center for Vasculitis Care and Research demonstrated that patients receiving low-dose aspirin or coumadin for cardiovascular risk had fewer ischemic events (visual loss and stroke) at presentation and in the course of therapy for giant cell arteritis (GCA).

Vision loss and cerebrovascular accidents are frequent in GCA. Antiplatelet and anticoagulant therapies reduce the risk of stroke in other populations. We sought to determine whether antiplatelet or anticoagulant therapy reduces ischemic complications in patients with GCA. A total of 143 cases were included with mean follow-up of 5 years. The cohort included 109 women (76%) and 34 men (24%); mean age was 71.8 years. A total of 104 (73%) patients had a biopsy-proven diagnosis. Eighty-six (60.1%) patients had received chronic antiplatelet or anticoagulant therapy, including 18 (12.6%) who did not start therapy until after an ischemic event had occurred. Antiplatelet agents or anticoagulants were not used in 57 (39.9%) patients. Overall, 11 of 68 (16.2%) patients suffered an ischemic event while receiving antiplatelet or anticoagulant therapy vs. 36 of 75 (48.0%) not receiving such therapy (p < 0.0005). Univariate analysis failed to show a statistical difference between groups in regard to cerebrovascular risk factors, age, gender or biopsy-proven diagnosis. Bleeding complications occurred in two patients taking aspirin, one patient taking warfarin, and five patients who did not receive anticoagulant or antiplatelet therapy.

Conclusions: Antiplatelet or anticoagulant therapy may reduce the risk of ischemic events in patients with GCA. An increased risk of bleeding complications was not observed.

Based on this analysis, we recommend low-dose aspirin therapy to all patients with GCA who have no contraindication to its use.

Characteristics of patients with or without ischemic events secondary to Giant Cell Arteritis*

Ischemic event No ischemic event P

Age, years 71.1 73.3 0.15

Female, % 67.4 80.4 0.10

ESR, mm/hour 66.3 85.5 0.03

Platelet count, X103/mm3 392 383 NS

Biopsy-proven diagnosis, % 76.1 71.1 NS

Cerebrovascular risk factors, % 67.4 69.1 NS

Aspirin at time of event, % 17.4 48.5 <0.0005

Warfarin at time of event, % 4.4 13.2 0.04†

Clopidogrel at time of event, % 2 1 NS

* Except where indicated otherwise, values are the mean. An ischemic event represents vision loss or hemispheric stroke secondary to GCA.

†By mulitivariate logistic regression analysis.

Outcomes 2007 54

Percent SurvivalPercent Survival

0

20

40

60

80

100WG

p=0.042

Control

0 50 100

Months

150 200 250

Percent SurvivalPercent Survival

0

20

40

60

80

100WG Control

p=0.0015

0 50 100 150 200 250

Months

Graft Survival

Patient Survival

Patients with WG are suitable candidates for transplant.

WG 4.4 36.1

Recurrent disease Chronic rejection

Controls 4.4 33.9

Frequencies (%) of cause for graft loss

Renal Graft Survival and Patient Mortality in Wegener’s Granulomatosis: A Case/Controlled Study Curry L Koening, Carol A. Langford, H. Lester Kirchner, Andrew O’Connor, Emilio Poggio, Gary S. Hoffman

Renal transplantation in patients with Wegener’s granulomatosis is as safe and effective as in other patients with end-stage renal disease (ESRD). These conclusions are based on a recently completed study by members of the Center for Vasculitis Care and Research. This study has been presented at the international annual meeting of the American College of Rheumatology by one of our research fellows in vasculitis.

Background: Kidney transplantation is an important medical advance for patients with ESRD due to Wegener’s granulomatosis (WG). This study used data from the United States Renal Data System (USRDS) to compare renal graft survival and patient mortality rates in patients who underwent transplant for WG to patients who underwent transplant for other causes of ESRD.

Results: A total of 712 WG patients were matched to 1,424 controls. One hundred fifty-eight (22%) grafts failed in patients who underwent transplant for WG compared with 366 (26%) failed grafts in controls who underwent transplant (P = 0.04). Recurrent disease as a cause of graft failure occurred in 4.4% of both groups. The 5-year allograft survival rate for patients with WG and controls was 86.9% (95% CI 84.2-89.2) and 82.7% (95% CI 80.6-84.6), respectively. A total of 137 (19%) patients with WG died compared with 361 (25%) controls (p = 0.002). Infection was the most common cause of death in patients with WG (N=29, 21%). The 5-year patient survival rate for WG was 89.9% (95% CI 87.4-91.9) compared with 85.7% (95% CI 83.7-87.4) in controls.

Conclusions: Transplant recipients with WG had a lower rate of graft failure and mortality than patients who underwent transplants for other causes. Recurrent disease was an uncommon cause of graft loss.


Substitution of methotrexate for cyclophosphamide in Wegener’s granulomatosis: a 12-year single-practice experience Villa-Forte A, Clark TM, Gomes M, Carey J, Mascha E, Karafa MT, Roberson G, Langford CA, Hoffman GS. Medicine. 2007; 86: 86(5):269-77.

Limiting use of cyclophosphamide (Cytoxan) for Wegener’s granulomatosis can eliminate the risk of cystitis and bladder cancer.

Prolonged or repeated courses of daily cyclophosphamide increase the risk of bone marrow suppression, infections, cystitis, bladder cancer and other malignancies, myelodysplasia and gonadal failure.

We conducted a retrospective review to assess outcomes of therapy in patients with newly diagnosed Wegener granulomatosis (WG) using methotrexate (MTX) for mild to moderate disease and short-term treatment with cyclophosphamide (CYC) followed by MTX for severe disease. Patients with WG were included if their initial plan of therapy and subsequent care were directly supervised by the Cleveland Clinic Center for Vasculitis Care and Research. Severe disease (immediately life-threatening or involving critical organs) was initially treated with CYC and glucocorticoids. Mild to moderate disease was initially treated with MTX and glucocorticoids if serum creatinine was less than 2 mg/dL. Following initial improvement of severe disease, treatment was changed to MTX if serum creatinine was originally less than 2 mg/dL or had diminished to less than 2 mg/dL. Disease activity was determined at each visit and later converted to a Birmingham Vasculitis Activity Score, as modified for Wegener granulomatosis (BVAS/WG). Laboratory monitoring of disease and treatment toxicity was initially weekly and never less than monthly. Eighty-two (32%) of 253 patients with WG referred to the Center for Vasculitis Care and Research met eligibility criteria. Ineligible patients did not have new-onset disease or were not able to be followed principally in our center.

Seventy percent of patients (57/82) initially had severe disease and received a short course of CYC for remission induction. In more than half of these patients, illness was judged to be severe because of pulmonary hemorrhage or rapidly progressive glomerulonephritis, including need for dialysis or neurologic abnormalities. All patients had improvement: remission was achieved in 50% (41/82) of patients within 6 months and in 72% (59/82) within 12 months. Sustained remission (BVAS/WG = 0 for at least 6 consecutive months) was ultimately achieved in 78% (64/82) of patients. Among the 75 (91%) patients who achieved remission of any duration, 45% had relapse within 1 year and 66% had relapse within 2 years following remission. Eighty-two percent of patients with relapse achieved subsequent remissions after additional treatment. About three-quarters of relapses were mild and promptly responded to treatment. Only 17% of patients developed serious infections. CYC-associated cystitis or bladder cancer did not occur in any patients. However, about three-quarters of all patients suffered some form of permanent morbidity. Mortality was only 3.7% and none of the 3 deaths were due to WG.

This experience supports our prior recommendations to avoid long-term therapy with CYC and use MTX for mild to moderate disease from the start of therapy, or after severe disease has improved after initial therapy with CYC. The high relapse rate following discontinuation of medication and high frequency of permanent morbidity also emphasizes the need for even better therapies.

Outcomes for new-onset WG. 1Four (1.3%) patients excluded - following CYC, these patients were treated with azathioprine. 2Sustained remission: BVAS/WG = 0 for at least 6 months.

*Death not related to active WG.

Referral cohort #253

New-onset WG #861

Initial treatment (#82) MTX (25) or CYC (57) changed

to MTX

Total number to achieve remission 75/82 (91%)

Transient remission <6 months = 18 (22%)

Relapse

1 death*

2 deaths*

Sustained remission2 64 (78%)

Subsequent relapse 57%

Æ ÆÆ

ÆÆ

Æ

ÆÆ

Æ

Outcomes 2007 56

Percent RemissionPercent Remission

0

20

40

60

80

100

0 4 8 12 16 20 24 28

Follow-up (months)

32 36 40 44 48 52 56 60

Time to remission did not differ between groups in whom treatment was inintiated with CYC vs. MTX.

Permanent Morbidity No. % (N = 82)

Chronic lung disease 10 12.2

Chronic sinus disease 36 43.9

Saddle nose 10 12.2

Dialysis 6 7.3

Renal transplant 4 4.9

Visual loss 3 3.7

Subglottic stenosis requiring tracheotomy 0 0

Subglottic stenosis not requiring tracheotomy 4 4.9

Hearing loss 23 28.1

Gangrene 1 1.2

Lymphoma 0 0.0

Bladder cancer 0 0

Other cancer 0 0.0

At least 1 of these chronic morbidities present 61 74.4


“Wrist-Fit” Anatomically Specific Fixation for Unstable Distal Radius Fractures

Dr. William Seitz has worked on the design and testing of a new minimally invasive fracture fixation system for the distal radius, which is specific to the anatomy of the distal radius. The system was designed using the Hahmann-Todd skeletal collection from the Museum of Natural History of Cleveland. Exact cast models of a selection of the two dozen distal radii from the smallest to the largest were taken and the surfaces digitally scanned to develop a low-profile plating system designed to contour to the anatomy of the palmar radial and dorsal surfaces of the distal radius. These implants are flexible enough to create a combined buttress plate and tension band effect, creating an extremely strong construct without the need for locking screw technology. Biomechanical studies have been carried out, which demonstrate stability, rigidity and ability to maintain reduction comparable to a variety of fixed angled locking plates. In addition, the anatomy-specific nature of the plates allows precise, secure dorsal and volar corner fragment fixation not possible with a uniplanar volar locking plate, which helps to secure and stabilize an otherwise unstable distal radio-ulnar joint.

A total of 51 patients have been treated with this FDA approved new “Anatomy-Specific” implant system. Of the 51 patients, 37 patients had acute fractures of the distal radius that were comminuted, unstable and intraarticular. The results were evaluated using the NYOH Wrist-Rating Scale, which equally weighs objective and subjective findings. A “fair” result would be the equivalent of a well-performed wrist arthrodesis (fusion). At the 1-year follow-up, using the NYOH, 24 patients were rated “excellent,” and 13 were rated “good.”There were no “fair” or “poor” results.

Fourteen patients were treated using the same implants for a variety of reconstructive procedures (partial radio-carpal arthrodesis, osteotomy for realignment of malunited fractures, management of non-united fractures). These are a more complex subset of patients with “limited goals.” None of these patients demonstrated any complications relative to the implants, and all implants functioned well for stable fixation.

Outcomes 2007 58

New KnowledgeJournal ArticlesAndrish J. Surgical options for patellar stabilization in the skeletally immature patient. Sports Med Arthrosc. 2007 Jun;15(2):82-88.

Au A, Boehm CA, Mayes AM, Muschler GF, Griffith LG. Formation of osteogenic colonies on well-defined adhesion peptides by freshly isolated human marrow cells. Biomaterials. 2007 Apr;28(10):1847-1861.

Aurora A, McCarron J, Iannotti JP, Derwin K. Commercially available extracellular matrix materials for rotator cuff repairs: state of the art and future trends. J Shoulder Elbow Surg. 2007 Sep;16(5 Suppl):S171-S178.

Barsoum WK, Patterson RW, Higuera C, Klika AK, Krebs VE, Molloy R. A computer model of the position of the combined component in the prevention of impingement in total hip replacement. J Bone Joint Surg Br. 2007 Jun;89(6):839-845.

Boyan BD, Schwartz Z, Patterson TE, Muschler G. Clinical use of platelet-rich plasma in orthopaedics. AAOS Now. 2007 Sep;1(7).

Brems JJ. Role of bone graft substitutes for glenoid bone defects. J Shoulder Elbow Surg. 2007 Sep;16(5 Suppl):S282-S285.

Brems JJ. Rehabilitation after total shoulder arthroplasty: Current concepts. Semin Arthroplasty. 2007 Mar;18(1):55-65.

Brems JJ. Anterior instability should be treated arthroscopically-Opposes. Semin Arthroplasty. 2007 Mar;18(1):7-10.

Brems JJ. Cuff tear arthropathy humeral head replacement: When more is better. Semin Arthroplasty. 2007 Mar;18(1):45-48.

Brooks PJ, Keramati M, Wickline A. Thromboembolism in patients undergoing total knee arthroplasty with epidural analgesia. J Arthroplasty. 2007 Aug;22(5):641-643.

Brooks PJ. Managing minor bone loss: grafts and augments. Orthopedics. 2007 Sep;30(9):795-796.

Budhabhatti SP, Erdemir A, Petre M, Sferra J, Donley B, Cavanagh PR. Finite element modeling of the first ray of the foot: a tool for the design of interventions. J Biomech Eng. 2007 Oct;129(5):750-756.

Calabrese LH, Molloy ES, Huang D, Ransohoff RM. Progressive multifocal leukoencephalopathy in rheumatic diseases: evolving clinical and pathologic patterns of disease. Arthritis Rheum. 2007 Jul;56(7):2116-2128.

Calabrese LH, Molloy ES, Singhal AB. Primary central nervous system vasculitis: progress and questions. Ann Neurol. 2007 Nov;62(5):430-432.

Calabrese LH, Dodick DW, Schwedt TJ, Singhal AB. Narrative review: reversible cerebral vasoconstriction syndromes. Ann Intern Med. 2007 Jan 2;146(1):34-44.

Carlisle JC, Parker RD, Matava MJ. Technical considerations in revision anterior cruciate ligament surgery. J Knee Surg. 2007 Oct;20(4):312-322.

Chambers B, St Clair SF, Froimson MI. Hydroxyapatite-coated tapered cementless femoral components in total hip arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):71-74.

Chao ST, Joyce MJ, Suh JH. Treatment of heterotopic ossification. Orthopedics. 2007 Jun;30(6):457-464.

staff authored more

than 200 publications

in 2007. For a

complete list go to

www.clevelandclinic.

org/quality/outcomes

Orthopaedic & Rheumatologic Institute


Codsi MJ, Hennigan S, Herzog R, Kella S, Kelley M, Leggin B, Williams GR, Iannotti JP. Latissimus dorsi tendon transfer for irreparable posterosuperior rotator cuff tears. Surgical technique. J Bone Joint Surg Am. 2007 Mar;89 Suppl 2:1-9.

Codsi MJ, Bennetts C, Powell K, Iannotti JP. Locations for screw fixation beyond the glenoid vault for fixation of glenoid implants into the scapula: An anatomic study. J Shoulder Elbow Surg. 2007 May;16(3 Suppl):S84-S89.

Deal CL. Absolute fracture risk. Curr Rheumatol Rep. 2007 Feb;9(1):66-70.

Deal CL, Hooker R, Harrington T, Birnbaum N, Hogan P, Bouchery E, Klein-Gitelman M, Barr W. The United States rheumatology workforce: supply and demand, 2005-2025. Arthritis Rheum. 2007 Mar;56(3):722-729.

DeFranco MJ, Bershadsky B, Ciccone J, Yum JK, Iannotti JP. Functional outcome of arthroscopic rotator cuff repairs: a correlation of anatomic and clinical results. J Shoulder Elbow Surg. 2007 Nov;16(6):759-765.

Derwin KA, Baker AR, Codsi MJ, Iannotti JP. Assessment of the canine model of rotator cuff injury and repair. J Shoulder Elbow Surg. 2007 Sep;16(5 Suppl):S140-S148.

Deutsch A, Abboud JA, Kelly J, Mody M, Norris T, Ramsey ML, Iannotti JP, Williams GR. Clinical results of revision shoulder arthroplasty for glenoid component loosening. J Shoulder Elbow Surg. 2007 Nov;16(6):706-716.

Donley BG, Moore T, Sferra J, Gozdanovic J, Smith R. The efficacy of oral nonsteroidal anti-inflammatory medication (NSAID) in the treatment of plantar fasciitis: A randomized, prospective, placebo-controlled study. Foot Ankle Int. 2007 Jan;28(1):20-23.

Donley BG, Jambor C, Erdermier A, Sferra J, Cavanagh P. Effect of pilot-hole size on the pullout strength of flexor digitorum longus transfer fixed with a bioabsorbable screw. Foot Ankle Int. 2007 Oct;28(10):1078-1081.

Eagleton MJ, Schaffer JL. The vascular surgery operating room: Development of an up-to-date operating room that will meet the demands of the vascular surgery patient and team. Endovascular Today. 2007 Aug;6(8):25-30.

Feller JA, Amis AA, Andrish JT, Arendt EA, Erasmus PJ, Powers CM. Surgical biomechanics of the patellofemoral joint. Arthroscopy. 2007 May;23(5):542-553.

Finkielman JD, Merkel PA, Schroeder D, Hoffman GS, Spiera R, St Clair EW, Davis JC Jr, McCune WJ, Lears AK, Ytterberg SR, Hummel AM, Viss MA, Peikert T, Stone JH, Specks U. Antiproteinase 3 antineutrophil cytoplasmic antibodies and disease activity in Wegener granulomatosis. Ann Intern Med. 2007 Nov 6;147(9):611-619.

Froimson MI, Garino J, Machenaud A, Vidalain JP. Minimum 10-year results of a tapered, titanium, hydroxyapatite-coated hip stem: An independent review. J Arthroplasty. 2007 Jan;22(1):1-7.

Goodwin RC, Mahar AT, Oswald TS, Wenger DR. Screw head impingement after in situ fixation in moderate and severe slipped capital femoral epiphysis. J Pediatr Orthop. 2007 Apr;27(3):319-325.

Goodwin RC, Mahar A, Wedemeyer M, Wenger D. Abductor length alterations in hips with SCFE deformity. Clin Orthop Relat Res. 2007 Jan;454:163-168.

Hanypsiak B, Bergfeld JA, Miniaci A, Joyce MJ. Recurrent compartment syndrome after fracture of a tibiofibular synostosis in a national football league player. Am J Sports Med. 2007 Jan;35(1):127-130.

Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, Salvarani C, Xu W, Visvanathan S, Rahman MU. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med. 2007 May 1;146(9):621-630.

Husni ME, Meyer KH, Cohen DS, Mody E, Qureshi AA. The PASE questionnaire: pilot-testing a psoriatic arthritis screening and evaluation tool. J Am Acad Dermatol. 2007 Oct;57(4):581-587.

Ilaslan H, Iannotti JP, Recht MP. Deltoid muscle and tendon tears in patients with chronic rotator cuff tears. Skeletal Radiol. 2007 Jun;36(6):503-507.

Jones MH, Amendola A. Syndesmosis sprains of the ankle: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:173-175.

Jones MH, Amendola AS. Acute treatment of inversion ankle sprains: immobilization versus functional treatment. Clin Orthop Relat Res. 2007 Feb;455:169-172.

Joy SM. Predicting lower extremity stress fractures in young women recruited into the Marine Corps. Clin J Sport Med. 2007 Jan;17(1):80-81.

Knothe Tate ML, Ritzman TF, Schneider E, Knothe UR. Testing of a new one-stage bone-transport surgical procedure exploiting the periosteum for the repair of long-bone defects. J Bone Joint Surg Am. 2007 Feb;89(2):307-316.

Landau DA, Saadoun D, Calabrese LH, Cacoub P. The pathophysiology of HCV induced B-cell clonal disorders. Autoimmun Rev. 2007 Sep;6(8):581-587.

Langford CA. Small-vessel vasculitis: Therapeutic management. Curr Rheumatol Rep. 2007 Aug;9(4):328-335.

Langford CA, Hoffman GS. Should induction therapy with high-dose glucocorticoids be the standard treatment for all patients with giant cell arteritis? Nat Clin Pract Rheumatol. 2007 Mar;3(3):132-133.

Langford CA. Vasculitis in the geriatric population. Rheum Dis Clin North Am. 2007 Feb;33(1):177-195.

Lawton JN, Nicholls MA, Charoglu CP. Immobilization for scaphoid fracture: forearm rotation in long arm thumb-spica versus Munster thumb-spica casts. Orthopedics. 2007 Aug;30(8):612-614.

Outcomes 2007 60

Miniaci A, Martineau PA. Technical aspects of osteochondral autograft transplantation. Instr Course Lect. 2007;56:447-455.

Mody E, Husni ME, Schur P, Qureshi AA. Multidisciplinary evaluation of patients with psoriasis presenting with musculoskeletal pain: a dermatology: rheumatology clinic experience. Br J Dermatol. 2007 Nov;157(5):1050-1051.

Molloy ES, Hajj-Ali RA. Primary angiitis of the central nervous system. Curr Treat Options Neurol. 2007 May;9(3):169-175.

Molloy ES, Morgan MP, McDonnell B, O’Byrne J, McCarthy GM. BCP crystals increase prostacyclin production and upregulate the prostacyclin receptor in OA synovial fibroblasts: potential effects on mPGES1 and MMP-13. Osteoarthritis Cartilage. 2007 Apr;15(4):414-420.

Molloy ES. Challenges of differential diagnosis: The pulmonary-renal syndrome and aortitis. International Journal of Advances in Rheumatology. 2007;4(4):120-127.

Moorthy LN, Peterson MGE, Baratelli M, Harrison MJ, Onel KB, Chalom EC, Haines K, Hashkes PJ, Lehman TJA. Multicenter validation of a new quality of life measure in pediatric lupus. Arthritis Rheum. 2007 Oct 15;57(7):1165-1173.

Murray T, Cooperman DR, Thompson GH, Ballock RT. Closed reduction for treatment of developmental dysplasia of the hip in children. Am J Orthop. 2007 Feb;36(2):82-84.

Murray TG, Parker RD. Restoring cartilage defects: microfracture to autologous chondrocyte implantation using investigational 3D scaffold. Orthopedics. 2007 Sep;30(9):766-767.

Neckers AC, Polster JM, Winalski CS, Krebs VE, Sundaram M. Comparison of MR arthrography with arthroscopy of the hip for the assessment of intra-articular loose bodies. Skeletal Radiol. 2007 Oct;36(10):963-967.

Parker RD, Streem K, Schmitz L, Group M, Martineau PA. Efficacy of continuous intra-articular bupivacaine infusion for postoperative analgesia after anterior cruciate ligament reconstruction: A double-blinded, placebo-controlled, prospective, and randomized study. Am J Sports Med. 2007 Apr;35(4):531-536.

Patel PD, Potts A, Froimson MI. The dislocating hip arthroplasty: prevention and treatment. J Arthroplasty. 2007 Jun;22(4 Suppl 1):86-90.

Powell KA, Nakamoto C, Villarruel S, Boehm C, Muschler G. Quantitative image analysis of connective tissue progenitors. Anal Quant Cytol Histol. 2007 Apr;29(2):112-121.

Recht MP, Grooff P, Ilaslan H, Recht HS, Sferra J, Donley BG. Selective atrophy of the abductor digiti quinti: an MRI study. AJR Am J Roentgenol. 2007 Sep;189(3):W123-W127.

Lawton JN, Cameron-Donaldson M, Blazar PE, Moore JR. Anatomic considerations regarding the posterior interosseous nerve at the elbow. J Shoulder Elbow Surg. 2007 Jul;16(4):502-507.

Lietman SA, Prescott NL, Hicks DG, Westra WH, Levine MA. SH3BP2 is rarely mutated in exon 9 in giant cell lesions outside cherubism. Clin Orthop Relat Res. 2007 Jun;459:22-27.

Lietman SA, Schwindinger WF, Levine MA. Genetic and molecular aspects of McCune-Albright syndrome. Pediatr Endocrinol Rev. 2007 Aug;4 Suppl 4:380-385.

Lietman SA, Barsoum WK, Goldblum JR, Marks KE, Mascha E, Sundaram M, Muschler G. A 20-year retrospective review of surgically treated liposarcoma at the Cleveland Clinic. Orthopedics. 2007 Mar;30(3):227-234.

Maksimowicz-McKinnon K, Clark TM, Hoffman GS. Limitations of therapy and a guarded prognosis in an American cohort of Takayasu arteritis patients. Arthritis Rheum. 2007 Mar;56(3):1000-1009.

Maksimowicz-McKinnon K, Hoffman GS. Takayasu arteritis: What is the long-term prognosis? Rheum Dis Clin North Am. 2007 Nov;33(4):777-786.

Maron BJ, Thompson PD, Ackerman MJ, Balady G, Berger S, Cohen D, Dimeff R, Douglas PS, Glover DW, Hutter AM Jr, Krauss MD, Maron MS, Mitten MJ, Roberts WO, Puffer JC. Recommendations and considerations related to preparticipation screening for cardiovascular abnormalities in competitive athletes: 2007 update: a scientific statement from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: endorsed by the American College of Cardiology Foundation. Circulation. 2007 Mar 27;115(12):1643-455.

Maschke SD, Evans PJ, Schub D, Drake R, Lawton JN. Radiographic evaluation of dorsal screw penetration after volar fixed-angle plating of the distal radius: A cadaveric study. Hand. 2007 Sep;2(3):144-150.

Maschke SD, Seitz W, Lawton J. Radial longitudinal deficiency. J Am Acad Orthop Surg. 2007 Jan;15(1):41-52.

Mata A, Boehm C, Fleischman AJ, Muschler GF, Roy S. Connective tissue progenitor cell growth characteristics on textured substrates. Int J Nanomedicine. 2007;2(3):389-406.

McAllister DR, Joyce MJ, Mann BJ, Vangsness CT Jr. Allograft update: the current status of tissue regulation, procurement, processing, and sterilization. Am J Sports Med. 2007 Dec;35(12):2148-2158.

McLean SG, Felin RE, Suedekum N, Calabrese G, Passerallo A, Joy S. Impact of fatigue on gender-based high-risk landing strategies. Med Sci Sports Exerc. 2007 Mar;39(3):502-514.

Miniaci A, Tytherleigh-Strong G. Fixation of unstable osteochondritis dissecans lesions of the knee using arthroscopic autogenous osteochondral grafting (mosaicplasty). Arthroscopy. 2007 Aug;23(8):845-851.


Riccardi M, Dimeff RJ. A high school soccer player with energy deficiency: A sports dietitian’s approach. Curr Sports Med Rep. 2007 Jul;6(4):219-224.

Rosneck J, Higuera CA, Tadross N, Krebs V, Barsoum WK. Managing knee osteoarthritis before and after arthroplasty. Cleve Clin J Med. 2007 Sep;74(9):663-671.

Scalise JJ, Miniaci A, Iannotti JP. Resurfacing arthroplasty of the humerus: Indications, surgical technique, and clinical results. Techniques in Shoulder & Elbow Surgery. 2007 Sep;8(3):152-160.

Scott J, Lee H, Barsoum W, van den Bogert AJ. The effect of tibiofemoral loading on proximal tibiofibular joint motion. J Anat. 2007 Nov;211(5):647-653.

Sebastian JK, Mahr AD, Ahmed SS, Stone JH, Romay-Penabad Z, Davis JC, Hoffman GS, McCune WJ, St Clair EW, Specks U, Spiera R, Pierangeli S, Merkel PA. Antiendothelial cell antibodies in patients with Wegener’s granulomatosis: prevalence and correlation with disease activity and manifestations. J Rheumatol. 2007 May;34(5):1027-1031.

Seitz WH Jr, Raikin SM. Resection of comminuted ulna head fragments with soft tissue reconstruction when associated with distal radius fractures. Tech Hand Up Extrem Surg. 2007 Dec;11(4):224-230.

Seitz WH Jr. Cup arthroplasty for shoulder resurfacing: Technical tips and “pearls.” Semin Arthroplasty. 2007 Mar;18(1):33-41.

Seitz WH Jr, Matsuoka H, McAdoo J, Sherman G, Stickney DP. Acute compression of the median nerve at the elbow by the lacertus fibrosus. J Shoulder Elbow Surg. 2007 Jan;16(1):91-94.

Seo P, Luqmani RA, Flossmann O, Hellmich B, Herlyn K, Hoffman GS, Jayne D, Kallenberg CGM, Langford CA, Mahr A, Matteson EL, Mukhtyar CB, Neogi T, Rutgers A, Specks U, Stone JH, Ytterberg SR, Merkel PA. The future of damage assessment in vasculitis. J Rheumatol. 2007 Jun;34(6):1357-1371.

Shapiro PS, Rohde RS, Froimson MI, Lash RH, Postak P, Greenwald AS. The effect of local corticosteroid or ketorolac exposure on histologic and biomechanical properties of rabbit tendon and cartilage. Hand. 2007 Dec;2(4):165-172.

Stefancin JJ, Parker RD. First-time traumatic patellar dislocation: A systematic review. Clin Orthop Relat Res. 2007 Feb;455:93-101.

Steiner TM, Matava MJ, Parker RD. Revision anterior cruciate ligament reconstruction with combined medial or lateral instability. J Knee Surg. 2007 Oct;20(4):323-329.

Sundaram M, Bauer T, von Hochstetter A, Ilaslan H, Joyce M. Intraosseous myelolipoma. Skeletal Radiol. 2007 Dec;36(12):1181-1184.

Tajaddini A, Scoffone HM, Botek G, Davis BL. Laser-induced auto-fluorescence (LIAF) as a method for assessing skin stiffness preceding diabetic ulcer formation. J Biomech. 2007;40(4):736-741.

Takigami H, Kumagai K, Latson L, Togawa D, Bauer T, Powell K, Butler RS, Muschler GF. Bone formation following OP-1 implantation is improved by addition of autogenous bone marrow cells in a canine femur defect model. J Orthop Res. 2007 Oct;25(10):1333-1342.

Ting TV, Scalzi LV, Hashkes PJ. Nonclassic neurologic features in cryopyrin-associated periodic syndromes. Pediatr Neurol. 2007 May;36(5):338-341.

Trepman E, Lutter LD, Richardson EG, Brodsky JW, Donley BG. Special report: highlights of the 22nd Annual Summer Meeting of the American Orthopaedic Foot and Ankle Society, La Jolla, California, July 14-16, 2006. Foot Ankle Int. 2007 May;28(5):646-653.

Uziel Y, Friedland O, Jaber L, Press J, Buskila D, Hashkes PJ. Living with children with growing pains: How does it affect the parents? Journal of Musculoskeletal Pain. 2007;15(2):19-23.

Vassilopoulos D, Calabrese LH. Risks of immunosuppressive therapies including biologic agents in patients with rheumatic diseases and co-existing chronic viral infections. Curr Opin Rheumatol. 2007 Nov;19(6):619-625.

Villa-Forte A, Clark TM, Gomes M, Carey J, Mascha E, Karafa MT, Roberson G, Langford CA, Hoffman GS. Substitution of methotrexate for cyclophosphamide in Wegener granulomatosis: a 12-year single-practice experience. Medicine (Baltimore). 2007 Sep;86(5):269-277.

Wang L, Shao YY, Ballock RT. Thyroid hormone interacts with the Wnt/beta-catenin signaling pathway in the terminal differentiation of growth plate chondrocytes. J Bone Miner Res. 2007 Dec;22(12):1988-1995.

Whyte MP, Mumm S, Deal C. Adult hypophosphatasia treated with teriparatide. J Clin Endocrinol Metab. 2007 Apr;92(4):1203-1208.

Williams GN, Jones MH, Amendola A. Syndesmotic ankle sprains in athletes. Am J Sports Med. 2007 Jul;35(7):1197-1207.

Williams GR Jr, Iannotti JP. Options for glenoid bone loss: composites of prosthetics and biologics. J Shoulder Elbow Surg. 2007 Sep;16(5 Suppl):S267-S272.

Wright RW, Kuhn JE, Amendola A, Jones MH, Spindler KP. Symposium integrating evidence-based medicine into clinical practice. J Bone Joint Surg Am. 2007 Jan;89(1):199-205.

Wright RW, Dunn WR, Amendola A, Andrish JT, Bergfeld J, Kaeding CC, Marx RG, McCarty EC, Parker RD, Wolcott M, Wolf BR, Spindler KP. Risk of tearing the intact anterior cruciate ligament in the contralateral knee and rupturing the anterior cruciate ligament graft during the first 2 years after anterior cruciate ligament reconstruction: a prospective MOON cohort study. Am J Sports Med. 2007 Jul;35(7):1131-1134.

Outcomes 2007 62

Wright RW, Dunn WR, Amendola A, Andrish JT, Flanigan DC, Jones M, Kaeding CC, Marx RG, Matava MJ, McCarty EC, Parker RD, Vidal A, Wolcott M, Wolf BR, Spindler KP. Anterior cruciate ligament revision reconstruction: two-year results from the MOON cohort. J Knee Surg. 2007 Oct;20(4):308-311.

Yavuz M, Erdemir A, Botek G, Hirschman GB, Bardsley L, Davis BL. Peak plantar pressure and shear locations: relevance to diabetic patients. Diabetes Care. 2007 Oct;30(10):2643-2645.

Yavuz M, Botek G, Davis BL. Plantar shear stress distributions: Comparing actual and predicted frictional forces at the foot-ground interface. J Biomech. 2007;40(13):3045-3049.

Orthopedic & Rheumatologic Institute: Anesthesiology Dilger JA, Tetzlaff JE. Total knee replacement (TKR). In: Bready LL, Dillman D, Noorily SH, eds. Decision-making in Anesthesiology: An Algorithmic Approach. 4th ed. Philadelphia, PA: Mosby Elsevier; 2007:538-541.

Evron S, Gladkov V, Sessler DI, Khazin V, Sadan O, Boaz M, Ezri T. Predistention of the epidural space before catheter insertion reduces the incidence of intravascular epidural catheter insertion. Anesth Analg. 2007 Aug;105(2):460-464.

Larson MD, Berry PD, May J, Bjorksten A, Sessler DI. Autonomic effects of epidural and intravenous fentanyl. Br J Anaesth. 2007 Feb;98(2):263-269.

Martinez V, Belbachir A, Jaber A, Cherif K, Jamal A, Ozier Y, Sessler DI, Chauvin M, Fletcher D. The influence of timing of administration on the analgesic efficacy of parecoxib in orthopedic surgery. Anesth Analg. 2007 Jun;104(6):1521-1527.

Martinez V, Fletcher D, Bouhassira D, Sessler DI, Chauvin M. The evolution of primary hyperalgesia in orthopedic surgery: quantitative sensory testing and clinical evaluation before and after total knee arthroplasty. Anesth Analg. 2007 Sep;105(3):815-821.

Rosencher N, Bonnet MP, Sessler DI. Selected new antithrombotic agents and neuraxial anaesthesia for major orthopaedic surgery: management strategies. Anaesthesia. 2007 Nov;62(11):1154-1160.

Smith MP, Helfand R, Tetzlaff JE. Anesthesia for shoulder surgery. In: Iannotti JP, Williams GR Jr, eds. Disorders of the Shoulder: Diagnosis & Management. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2007:1347-1364.

Tetzlaff JE. Skin and bone disorders. In: Fleisher LA (ed). Anesthesia and Uncommon Diseases. Philadelphia: Elsevier/Saunders, 2007:327-357.

Tetzlaff JE, Dilger JA. Total hip replacement (THR). In: Bready LL, Dillman D, Noorily SH, eds. Decision-making in Anesthesiology: An Algorithmic Approach. 4th ed. Philadelphia, PA: Mosby Elsevier; 2007:530-533.

Tetzlaff JE, Dilger JA. Shoulder surgery. In: Bready LL, Dillman D, Noorily SH, eds. Decision-making in Anesthesiology: An Algorithmic Approach. 4th ed. Philadelphia, PA: Mosby Elsevier; 2007:542-545.


Selected Research InitiativesHashkes, Philip A Pilot, Multi-center, Randomized, Double Blind, Placebo Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of Rilonacept (IL-1Trap) Administered Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Mandell, Brian F. Randomized, multicenter, double-blind, placebo-controlled efficacy and safety study of 8 mg PEG-uricase in two dose regimens in hyperuricemic subjects with symptomatic gout

Deal, Chad Open Label Proof of Concept Study of IV Zoledronic Acid (ZA) 5 mg after Forteo in Postmenopausal Women

Husni, Elaine PRECISION: Prospective Randomized Evaluation of Celocoxib Integrated Safety vs Ibuprofen Or Naproxen

Deal, Chad Study CR9108963: A 12 month, randomized, double-blind, parallel-group, placebo and active-controlled dose-range finding study of the efficacy and safety of SB751689 in postmenopausal women with osteoporosis

Langford, Carol Rare Diseases Clinical Research Network A Multi-Center, Open-label Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener’s Granulomatosis (WG), Vasculitis Clinical Research Consortium (VCRC)

Langford, Carol Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (RAVE)

Deal, Chad A Randomized, Double-Blind Study to Compare the Efficacy of Treatment with Denosumab versus Alendronate Sodium in Postmenopausal Women with Low Bone Mineral Density

WGET Research Group (Gary Hoffman, co-PI) Wegener’s Granulomatosis Etanercept Trial (WGET) Longitudinal Study

Hashkes, Philip Phase 2 Study of IL-1 Trap for Treatment of Familial Mediterranean Fever

Froimson, Mark DVT Prevention in THA: CECT vs. LMWH

Barsoum, Wael Efficacy of the bipolar sealer Aquamantys 6.0™ in Patients Undergoing Total Hip Arthroplasty

has been appointed to

the Board of Directors

of the Research

and Education

Foundation for the

American College of

Rheumatology.

was awarded a 3-year grant

from the American College

of Rheumatology for the

Clinical Scholar-Educators

Committee on Training

and Workforce, American

College of Rheumatology.

is Chairman of the

American College of

Rheumatology National

Meeting Planning

Committee.

Dr. Leonard Calabrese

Dr. Abby Abelson

Dr. Brian Mandell

Outcomes 2007 64

Staff Listing

ChairmanJoseph P. Iannotti, MD, PhD Professor, Cleveland Clinic Lerner College of Medicine

Department of Orthopaedic SurgeryJoseph P. Iannotti, MD, PhD, Interim Chairman

Foot and Ankle

Brian Donley, MD Director, Foot and Ankle Center Allan Boike, DPM Georgeanne Botek, DPM Robert Dushin, DPM James Hall, DPM Patrick McKee, DPM James Sferra, MD Dina Stock, DPM

Hand and Upper ExtremityPeter J. Evans, MD, PhD Director, Hand and Upper Extremity Center John Brems, MD Avrum Froimson, MD Joseph P. Iannotti, MD, PhD Jeffrey Lawton, MD Steven Maschke, MD Jesse McCarron, MD William H. Seitz Jr., MD

Joint Replacement and Adult Reconstructive SurgeryViktor Krebs, MD Director, Center for Joint Replacement and Adult Reconstructive Surgery George P. Balis, MD Wael Barsoum, MD Peter Brooks, MD Wayne Daum, MD Mark Froimson, MD Quality Review Officer

Michael Joyce, MD Ulf Knothe, MD Steven Lietman, MD Kenneth Marks, MD Mary-Blair Matejczyk, MD Robert Molloy, MD Michael Moore, MD George Muschler, MD Jonathan Schaffer, MD, MBA Daniel Single, MD Bernard N. Stulberg, MD Michael Walker, MD

Musculoskeletal Trauma and Tumor Center

Steven Lietman, MD, Director, Musculoskeletal Trauma and Tumor Center Michael Joyce, MD

Pediatric OrthopaedicsRobert Tracy Ballock, MD Director, Center for Pediatric Orthopaedics Jack Andrish, MD Ryan C. Goodwin, MD Alan Gurd, MD David Gurd, MD Thomas E. Kuivila, MD

Sports MedicineAnthony Miniaci, MD Executive Director, Center for Sports Health Thomas Anderson, MD Jack T. Andrish, MD John A. Bergfeld, MD Alfred Cianflocco, MD Alan Davis, MD Robert Dimeff, MD Rick Figler, MD Paul Gubanich, MD Morgan Jones, MD Susan Joy, MD Richard D. Parker, MD


Kelly Richter, MD Paul Saluan, MD Mark Schickendantz, MD James Williams, MD

Research StaffBoris Bershadsky, PhD Director, Clinical Outcomes Research Center (CORC) Stephen Fening, PhD Research Director, Cleveland Clinic Sports Health

Staff with Joint AppointmentsSuneel Apte, MBBS, DPhil Lerner Research Institute/Biomedical Engineering Thomas Bauer, MD Pathology and Laboratory Medicine Institute, Neurological Institute Gordon Bell, MD Neurological Institute Peter R. Cavanagh, PhD, DSc Lerner Research Institute/Biomedical Engineering Brian Davis, PhD Lerner Research Institute/Biomedical Engineering Kathleen Derwin, PhD Lerner Research Institute/Biomedical Engineering Vincent Hascall, PhD Lerner Research Institute/Biomedical Engineering Isador H. Lieberman, MD Spine Institute Florida, Neurological Institute, Taussig Cancer Institute Cahir McDevitt, PhD Lerner Research Institute/Biomedical Engineering Robert F. McLain, MD Lerner Research Institute/Biomedical Engineering; Neurological Institute Ronald Midura, PhD Lerner Research Institute/Biomedical Engineering Thomas Mroz, MD Neurological Institute R. Douglas Orr, MD Neurological Institute MD Takao Sakai, MD, PhD Lerner Research Institute/Biomedical Engineering Maria Siemionow, MD

Dermatology and Plastic Surgery Institute, Surgery Institute, Lerner Research Institute/Immunology Antonie van den Bogert, PhD Lerner Research Institute/Biomedical Engineering Guang Yue, PhD Lerner Research Institute/Biomedical Engineering, Rehabilitation Institute, Wellness Institute

Musculoskeletal Radiology StaffGeorge H. Belhobek, MD Stephen Hatem, MD Hakan Ilaslan, MD Patrick O’Keefe, MD David Piraino, MD Joshua Polster, MD Bradford J. Richmond, MD Michael Recht, MD Jean P. Schils, MD Naveen Subhas, MD Murali Sundaram, MD Carl S. Winalski, MD

Department of Rheumatic and Immunologic DiseaseAbby G. Abelson, MD Interim Chair, Department of Rheumatic and Immunologic Disease

General RheumatologyGary S. Hoffman, MD, MS Harold C. Schott Chair of Rheumatic and Immunologic Diseases; Professor, Cleveland Clinic Lerner College of Medicine

Matthew Bunyard, MD Director, Clinical Operations Abby G. Abelson, MD Director, Education Program Soumya Chatterjee, MD, MS Carmen Gota, MD Rula Hajj-Ali, MD Elaine Husni, MD, MPH Anna P. Koo, MD Brian F. Mandell, MD, PhD

Outcomes 2007 66

Raymond J. Scheetz, MD Alexandra Villa Forte, MD, MPH William S. Wilke, MD

Clinical ImmunologyLeonard H. Calabrese, DO R.J. Fasenmyer Chair in Clinical Immunology

Osteoporosis and Metabolic Bone DiseasesChad L. Deal, MD Director, Center for Osteoporosis and Metabolic Bone Diseases Abby Abelson, MD Elizabeth File, MD Bruce Long, MD Angelo Licata, MD, PhD Clinical Trials Director

Pediatric RheumatologyPhilip J. Hashkes, MD, MSc Head, Center for Pediatric Rheumatology Steven J. Spalding, MD

Vasculitis Care and ResearchCarol Langford, MD, MHS Director, Center for Vasculitis Care and Research Leonard H. Calabrese, DO Carmen Gota, MD Rula Hajj-Ali, MD Gary S. Hoffman, MD, MS Department Chairman Eamonn Molloy, MD, MRCPI Alexandra Villa Forte, MD, MPH

Regional Medical PracticesFeyrouz Al-Ashkar, MD (Lorain) Chad L. Deal, MD (Solon) Rajul Desai, MD, MPH (Solon) Howard Epstein, MD (Beachwood) Elizabeth File, MD (Strongsville) Janice Granieri, MD, PhD (Westlake) Bruce Long, MD (Luthern Hospital) Judith Manzon, MD (Westlake) Susan Mathai, MD (Westlake) Alla Modell, MD (Independence) Rochelle Rosian, MD (Solon) Jeffrey Wisnieski, MD (Willoughby Hills)

AnesthesiologyArmin Schubert, MD, MBA Chairman, General Anesthesiology

Robert Helfand, MD Section Head

Loran Mounir-Soliman, MD Associate Section Head

Harendra Arora, MD Charanjit Bahniwal, MD Matvey Bobylev, MD Raymond Borkowski, MD Demetrios Bourdakos, MD Michael Ritchey MD Brok Gretter, MD Stacy Ritzman, MD Mauricio Perilla M.D Ehab Farag M.D John Tetzlaff, MD

Some physicians may practice in multiple locations. For a detailed list including staff photos, please visit clevelandclinic.org/staff.


Contact Information Institute LocationsGeneral Patient Referral

24/7 hospital transfers or physician consults 800.553.5056

Joint Reconstruction, Pediatrics, Tumor and Trauma Appointments/Referrals

216.444.2606 or 800.223.2273, ext. 42606

Hand and Upper Extremity Appointments/Referrals Foot and Ankle/Podiatry Appointments/Referrals

216.444.6260 or 800.223.2273, ext. 46260

Sports Medicine Appointments/Referrals

216.444.2620 or 800.223.2273, ext. 42620

On the Web at clevelandclinic.org/ortho and clevelandclinic.org/arthritis

Main Campus

9500 Euclid Ave./A41 Orthopaedics Cleveland, OH 44195 216.444.2620

9500 Euclid Ave./A50 Rheumatology Cleveland, OH 44195 216.444.5632

Orthopaedics and Rheumatology Beachwood Family Health and Surgery Center

26900 Cedar Road Beachwood, OH 44122 216.839.3000

Brunswick Family Health Center

3574 Center Road Brunswick, OH 44212 330.225.8886

Independence Family Health Center

5001 Rockside Road Crown Center II Independence, OH 44131 216.986.4000

Solon Family Health Center

29800 Bainbridge Road Solon, OH 44139 440.519.6800

Strongsville Family Health and Surgery Center

16761 SouthPark Center Strongsville, OH 44136 440.878.2500

Westlake Family Health Center

30033 Clemens Road Westlake, OH 44145 440.899.5555

Additional Contact Information General Information 216.444.2200

Hospital Patient Information 216.444.2000

Patient Appointments 216.444.2273 or 800.223.2273

Special Assistance for Out-of-State Patients

Complimentary assistance for out-of-state patients and families

800.223.2273, ext. 55580, or email [email protected]

International Center

Complimentary assistance for international patients and families

800.884.9551 or 001. . . or visit clevelandclinic.org/ic216 444 6404

Cleveland Clinic in Florida

866.293.7866

For address corrections or changes, please call 800.890.2467

Outcomes 2007 68

Orthopaedic Surgery and Sports Health Only Cleveland Clinic and Euclid Hospital Sports Health & Rehabilitation – Willoughby Hills

29017 Chardon Road Willoughby Hills, OH 44092 440.516.5400

Orthopaedic Surgery - Euclid Hospital

Medical Office Building 99 Northline Circle, Suite 100 Euclid, OH 44119 216.692.7750

Sports Health & Rehabilitation at the Mandel Jewish Community Center

26001 South Woodland Road Beachwood, OH 44122 216.378.6240

Rehabilitation Only Cleveland Clinic and Euclid Hospital Sports Health & Rehabilitation – Mentor

7215 Center St. Mentor, OH 44060 440.205.1714 or 440.942.3120


Cleveland Clinic Overview Online Services

Cleveland Clinic, founded in 1921, is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Today, 1,800 Cleveland Clinic physicians and scientists practice in 120 medical specialties and subspecialties, annually recording more than 3 million patient visits and more than 70,000 surgeries.

In 2007, Cleveland Clinic restructured its practice, bundling all clinical specialties into integrated practice units called institutes. An institute combines all the specialties surrounding a specific organ or disease system under a single roof. Each institute has a single leader and focuses the energies of multiple professionals onto the patient. From access and communication to point-of-care service, institutes will improve the patient experience at Cleveland Clinic.

Cleveland Clinic’s main campus, with 37 buildings on 140 acres in Cleveland, Ohio, includes a 1,000-bed hospital, outpatient clinic, specialty institutes and supporting labs and facilities. Cleveland Clinic also operates 14 family health centers; eight community hospitals; two affiliate hospitals; a 150-bed hospital and clinic in Weston, Fla.; and health and wellness centers in Palm Beach, Fla., and Toronto, Canada. Cleveland Clinic Abu Dhabi (United Arab Emirates), a multispecialty care hospital and clinic, is scheduled to open in 2011.

At the Cleveland Clinic Lerner Research Institute, hundreds of principal investigators, project scientists, research associates and postdoctoral fellows are involved in laboratory-based research. Total annual research expenditures exceed $150 million from federal agencies, non-federal societies and associations, and endowment funds. In an effort to bring research from bench to bedside, Cleveland Clinic physicians are involved in more than 2,400 clinical studies at any given time.

In September 2004, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University opened and will graduate its first 32 students as physician-scientists in 2009.

Cleveland Clinic is consistently ranked among the top hospitals in America by U.S.News & World Report, and our heart and heart surgery program has been ranked No. 1 since 1995.

For more information about Cleveland Clinic, visit clevelandclinic.org.

eCleveland CliniceCleveland Clinic uses state-of-the-art digital information systems to offer several services, including remote second medical opinions to patients around the world; personalized medical record access for patients; patient treatment progress for referring physicians (see below); and imaging interpretations by our subspecialty trained radiologists. For more information, please visit eclevelandclinic.org.

DrConnectOnline Access to Your Patient’s Treatment Progress

Whether you are referring from near or far, DrConnect can streamline communication from Cleveland Clinic physicians to your office. This online tool offers you secure access to your patient’s treatment progress at Cleveland Clinic. With one-click convenience, you can track your patient’s care using the secure DrConnect website. To establish a DrConnect account, visit eclevelandclinic.org or email [email protected].

MyConsultMyConsult Remote Second Medical Opinion is a secure online service providing specialist consultations and remote second opinions for more than 600 life-threatening and life-altering diagnoses. The MyConsult service is particularly valuable for people who wish to avoid the time and expense of travel. For more information, visit eclevelandclinic.org/myconsult, email [email protected] or call 800.223.2273, ext 43223.

9500 Euclid Avenue, Cleveland, OH, 44195

© The Cleveland Clinic Foundation 2008

Cleveland Clinic is a nonprofit multispecialty academic medical center. Founded in 1921, it is dedicated to providing quality specialized care and includes an outpatient clinic, a hospital with more than 1,000 staffed beds, an education institute and a research institute.

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