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The Art of Orthopaedics

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Page 1: The Art of Orthopaedics

T h e A r t o f

O r t h o p a e d i c s

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1-800-JEFF-NOW | Jefferson.edu/Orthopedic | transfers: 1-800-JEFF-121 | physician referrals: 215-503-8888 A

ORTHOPAEDIC OUTCOMES AND

RESEARCH

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B Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

CONTENTS 2 TRANSFORMING CARE:

AN OVERVIEW

SPECIALTIES

4 COMPLEX SPINE

8 JOINT REVISION

14 HAND AND WRIST

20 MUSCULOSKELETAL ONCOLOGY

24 TRAUMA

28 ONGOING CLINICAL TRIALS

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11--800800--JEFFJEFF--NOW NOW || Jefferson.edu/OrthopedicJefferson.edu/Orthopedic || transfers: 1 transfers: 1--800800--JEFFJEFF--121 121 || physician referrals: 215-503-8888 physician referrals: 215-503-8888

Dear Colleagues,

I am pleased to share this Orthopaedic Outcomes and Research report, which highlights important clinical and research developments at Thomas Jefferson University Hospitals. This year’s report is titled Transforming Carebecause that is precisely what we are doing every day in Jefferson’s Department of Orthopaedic Surgery.

In the pages ahead you will see the many ways that orthopaedic specialists at Jefferson are committed to clinical excellence, research and education of other practitioners in the field. Our clinicians and scientists — including experts from the Rothman Institute at Jefferson and the Philadelphia Hand Center at Jefferson — are intent on transforming findings from laboratory studies and clinical research projects into new medical and surgical techniques that will improve the delivery of care and enhance patient outcomes by every measure.

Our research agenda is furthering the understanding of both ordinary and rare orthopaedic diseases, expanding diagnostic capabilities through the use of enhanced imaging techniques and novel biomarkers, and challenging conventional notions around orthopaedic surgery. Because of findings by our research team, for instance, certain patients undergoing orthopaedic surgery are now less likely to be placed on aggressive anticoagulation therapy or get a urinary catheter. Such seemingly simple changes are helping to improve the overall quality of care experienced by our patients.

Jefferson is honored to be the largest orthopaedic program in the Delaware Valley. Last year, through the collective experience of our orthopedic specialists, more than 36,000 surgical procedures were performed in eight specialty areas — hip and knee, spine, hand and wrist, musculoskeletal oncology, shoulder and elbow, sports medicine, foot and ankle and trauma. U.S.News & World Report ranks Jefferson’s orthopaedic program among the top 10 in the country.

I invite you to read this Outcomes and Research report to learn how Jefferson orthopaedic clinicians and scientists are Transforming Care through the development of new therapies, more effective clinical pathways and best practice methodologies.

More information about the orthopaedic services available at Jefferson can be found at our website, Jefferson.edu/Orthopedic. To refer a patient, please call 215-503-8888 or have your patient call 1-800-JEFF-NOW.

Thank you for your interest. I wish you much happiness and success in the New Year.

Alexander R. Vaccaro, MD, PhD

Richard H. Rothman Professor and Chair Department of Orthopaedic SurgeryThomas Jefferson University HospitalsSidney Kimmel Medical College at Thomas Jefferson University

A MESSAGE FROM THE CHAIR

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Orthopaedic care is central to the goal of keeping people active

throughout every decade of life. Whether the patient is a student athlete

struggling with an injury, a worker who has suffered a fall, or an octogenarian

with degenerative disc disease, the orthopaedic team at Jefferson’s

Department of Orthopaedic Surgery is committed to helping the patient

return to as full function as possible, free of pain.

This Orthopaedic Outcomes

and Research report, titled

Transforming Care, illustrates why

so many patients turn to Jefferson

for care. The orthopaedics team —

which includes specialists from

the Rothman Institute at Jefferson

and the Philadelphia Hand Center at Jefferson — utilize the latest in imaging

and diagnostic technologies, surgical and nonsurgical techniques, implant

materials, pain management, rehabilitation therapies and prevention measures

to deliver the highest level of care. U.S.News & World Report ranks Jefferson’s

orthopaedic program Number 8 in the nation.

Clinical practices are informed by a full research agenda that reaches

from the laboratory to the bedside and clinic. Jefferson researchers

are exploring the biology of orthopaedic diseases right down to

specific molecules and genes; testing new surgical materials that can

lead to better results; and taking part in studies of drug therapies

and surgical techniques that enhance recovery and quality of life.

Patients coming to Jefferson have access to clinical trials often found

nowhere else in the region.

TRANSFORMING

CARE a n o v e r v i e w

2 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

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326

366

7,268

2,279

9,174 JOINT SURGERIES

2,033 FOOT AND ANKLE SURGERIES

4,950 SPORTS MEDICINE CASES

MUSCULOSKELETAL ONCOLOGY CASES

TRAUMA CASES

2,762 SHOULDER AND ELBOW SURGERIES

HAND AND WRIST SURGERIES

SPINAL SURGERIES

By the Numbers January – September 2014

This report highlights recently published research from five of the

eight specialty areas of orthopaedic care at Jefferson:

• Joint Replacement (Or Hip and Knee). Jefferson researchers devised a risk

stratification system for assessing whether surgical patients are at high risk for

pulmonary embolism and in need of more aggressive anticoagulation prophylaxis.

• Spine. Amid a growing public health concern over opioid abuse,

researchers evaluated whether opioid medications help improve outcomes

for patients with back pain.

• Hand and Wrist. Researchers measured screws commonly used for finger

surgery to determine whether they are a good anatomical fit. They also

studied design aspects of volar locking plates.

• Musculoskeletal Oncology. Case reports on patients undergoing resection and

reconstruction for pelvis tumors demonstrated innovative approaches to surgery.

• Trauma. Researchers led a multi-center study that is helping to understand a

particular type of femur fracture that seems to be occurring more frequently.

Those studies and others detailed in this report illustrate the many ways that

Jefferson’s Department of Orthopaedic Surgery is working simultaneously to

advance research and improve patient outcomes. The goal of Transforming

Care is being realized.

1-800-JEFF-NOW | Jefferson.edu/Orthopedic | transfers: 1-800-JEFF-121 | physician referrals: 215-503-8888 3

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COMPLEX SPINE

4

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SERVICESSERVICES•• Treatment for cervical, Treatment for cervical,

thoracic and lumbosacral thoracic and lumbosacral

spinal conditionsspinal conditions

•• Treatment for scoliosis/Treatment for scoliosis/

spinal deformities, spinal deformities,

spondylolisthesis, spondylolisthesis,

spinal cord injury/spinal cord injury/

trauma, spinal infections trauma, spinal infections

and spinal tumorsand spinal tumors

•• Minimally invasive Minimally invasive

techniques and image-techniques and image-

guided technologyguided technology

•• Comprehensive treatment Comprehensive treatment

of disc disease, including of disc disease, including

disc replacementdisc replacement

WITH THE POPULATION AGING, THE NEED TO IDENTIFY THE

BEST SURGICAL AND NONSURGICAL APPROACHES TO TREATING

SPINAL DISORDERS HAS NEVER BEEN GREATER.

Jefferson spine surgeons are leaders in the treatment of traumatic and degenerative spine

disorders, from spinal cord injury and tumors to herniated discs and spinal stenosis. They routinely

treat complex spine issues and are leaders in the use of minimally invasive techniques for cases

that could benefit from that approach.

Patients arriving at Jefferson in an emergency situation benefit from the fact that the hospital is

both a designated Level 1 Trauma Center and a federally designated spinal cord injury center.

Through the collective experience of our orthopaedic spine specialists and under the supervision

of co-directors Alan Hilibrand, MD and Alexander Vaccaro, MD, PhD, more than 2,500 surgeries

were performed in 2014. Pain and loss of mobility are major concerns of spinal patients, and

Jefferson’s multidiscipline approach to treatment planning includes both attention to optimizing

pain management and enhancing recovery through rehabilitative therapy.

All care, whether emergency or non-urgent, delivered by Jefferson’s orthopaedic spine

specialists is informed by a robust research agenda that includes the testing of new diagnostic

and surgical techniques, as well as ways to better manage spinal conditions nonsurgically.

Here are two recent studies aimed at improving patient outcomes:

Comparison of Open and Minimally Invasive Techniques for Posterior Lumbar Instrumentation and Fusion After Anterior Lumbar Interbody FusionIt is sometimes automatically assumed that minimally invasive surgery (MIS) is superior to a

conventional approach. Minimally invasive techniques for spinal fusion would seem to provide

an advantage in reducing paraspinal muscle injury, osteoligamentous destabilization and

surgical morbidity, which can result in faster recovery for patients. But such assumptions need

to be objectively assessed to make sure that new minimally invasive techniques can

accomplish their surgical objectives while not compromising surgical outcomes or increasing

complications for patients.

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6 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

In a study published in The Spine Journal, a Jefferson research team headed by Christopher Kepler, MD, designed a case-controlled retrospective study to analyze whether using MIS for posterior fusion and instrumentation following open anterior lumbar interbody fusion (ALIF) was superior to using an open approach for pedicle screw placement and decompres-sion. The study involved 81 patients who underwent a combined open and MIS operation and 81 patients who had traditional open surgery for both stages of the ALIF operation. Among the findings:

• Following ALIF, MIS posterior fusion techniques resulted in less blood loss, less need for transfusions and shorter hospital stays compared to an open approach. The average hospital stay was reduced from 5.3 days to 4.4 days.

• The advantage of MIS over open surgery was less apparent in patients who underwent posterior decompression at the time of instrumentation.

• Fluoroscopy time was significantly greater with MIS — 1.5 minutes compared to 0.2 minutes for the open group.

• There were no significant differences between the MIS and open group when it came to infection and other complications, such as misplaced pedicle screws, a need for screw revision or pulmonary embolus.

“These data support the notion that MIS surgery has reduced operative morbidity and faster early recovery when used for posterior instrumentation but may not have significant benefits when a concomitant decompression is necessary,” the researchers concluded. “It should be acknowledged that benefits of MIS come at the cost of significantly higher use of ionizing radiation.”

The researchers said that larger studies with longer follow up are needed to determine long-term outcomes and complications related to MIS techniques

compared to traditional surgical approaches.

Does Opioid Pain Medication Use Affect the Outcome of Patients with Lumbar Disc Herniation?Opioid medications are often used for treatment of both acute and chronic back pain. Potential benefits of opioid use in patients with severe unremitting pain include decreased pain levels, functional improvement and improved mood and social function. However, there are significant societal concerns about the potential dangers of opioids, including side effects such as altered mental status, abuse of drugs, diversion of drugs to individuals other than the patient, and overdose. Also, there is the possibility that ongoing use of opioids to control pain could lead to tolerance and a need for escalating doses and ultimately, poorer

outcomes when surgical treatment is indicated. Despite such concerns, the use of opioid medication compared to nonpain medication (anti-inflammatory agents and muscle relaxants) is growing in the Medicare population.

Jefferson is part of a multi-center study called the SPORT trial that is evaluating surgical versus nonsurgical treatment of common lumbar degenerative conditions. As part of that effort, the researchers, headed by Kris Radcliff, MD, looked at the impact of opioids on outcomes of surgical and nonsurgical treatment of lumbar disc herniation. The study helped answer several important clinical questions. Do patients who take opioids fare better or worse over the long haul than those who don’t? Are they able to avoid surgery? Do they become dependent on opioids?

The study, published in Spine, compared 520 patients who did not receive opioids to 542 patients who did. The patients were assessed periodically — at baseline, three weeks, six weeks, six months, one year, two years, three years and four years following surgery. Primary outcome measures included the bodily pain (BP), physical functions (PF) and mental component summary (MCS) domains of the SF-36 and the AAOS version of the Oswestry Disability Index (ODI). Patient self-reports and several standardized pain severity assessment scales were used as secondary outcome

measures. Among the findings:

• Approximately 40 to 49 percent of study

participants were treated with opioid analgesics during the pre-enrollment period and 35 to 45 percent during the course of the study.

• Despite taking stronger pain medication, patients taking opioids had more pain and poorer quality of life and were more likely to report that their pain symptoms were worsening. They were more likely to

COMPLEX SPINE

1,000 1,500 2,000 2,500 3,000

YTD 2014 2,279

YTD 2013 2,255

TOTAL 2013 3,034

Surgery VolumeSource: Jefferson internal data

Calendar YTD through September

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have disability (18 versus 9 percent), have filed a compensation claim (24 versus 13 percent) and smoke (29 versus 19 percent) than patients not taking opioids at the start of the study. They also tended to be heavier and less educated.

• A higher percentage of opioid patients underwent surgery (75 percent) compared to non-opioid patients (59 percent).

• Patients who initially were treated nonsurgically were more likely to ultimately get surgery if they were taking opioids than if they didn’t take the drugs (45 versus 31 percent), suggesting that opioid medication did not relieve lower back pain enough to avoid surgery.

• At four-year follow up, there were no significant differences in measures of pain, degree of disability

and quality of life between the opioid and non-opioid groups.

• The incidence of opioid use at four years was 16 percent among patients who were using opioids at baseline and 5 percent among those who were not.

“Our results indicate no significant improvement in outcomes associated with opioid medication in the treatment of lumbar disc herniation whether treated surgically or nonsurgically,” the authors concluded. “Further study is required to determine if the transient pain relief offsets the risks of opioid addiction and overdose since there is no long-term benefit of opioid medications to patients.”

Based on the findings, Jefferson spine surgeons now minimize the use of opioids in patients who have problems that might benefit from surgical treatment.

0

5

10

15

20

25

1 year 2 years 3 years 4 years

25%

21%

17% 16%

8% 7% 6% 5%

0

010

20

30

40

50

60

3 6 12 24 36Months from Baseline

Surgery p-value = 0.96Non-operative p-value = 0.078

Interaction p-value = 0.15

BODILY PAIN

Ad

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48

Non-Operative: Had-NarcoticsSurgery: Had-Narcotics

Surgery: Non-Narcotics Non-Operative: Non-Narcotics

Surgery p-value = 0.84Non-operative p-value = 0.36

Interaction p-value = 0.55

PHYSICAL FUNCTION

Months from Baseline0 3 6 12 24 36 48

Surgery p-value = 0.84Non-operative p-value = 0.30

Interaction p-value = 0.34

OSWESTRY

Months from Baseline0 3 6 12 24 36 48

Does Opioid Pain Medication Use Affect the Outcomes for Patients with Lumbar Disc Herniation?

0

5

10

15

20

25

1 year 2 years 3 years 4 years

25%

21%

17% 16%

8% 7% 6% 5%

0

010

20

30

40

50

60

3 6 12 24 36Months from Baseline

Surgery p-value = 0.96Non-operative p-value = 0.078

Interaction p-value = 0.15

BODILY PAIN

Ad

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Di�

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Bas

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48

Non-Operative: Had-NarcoticsSurgery: Had-Narcotics

Surgery: Non-Narcotics Non-Operative: Non-Narcotics

Surgery p-value = 0.84Non-operative p-value = 0.36

Interaction p-value = 0.55

PHYSICAL FUNCTION

Months from Baseline0 3 6 12 24 36 48

Surgery p-value = 0.84Non-operative p-value = 0.30

Interaction p-value = 0.34

OSWESTRY

Months from Baseline0 3 6 12 24 36 48

Primary Outcomes Over Time for Non-Narcotics and Had-Narcotics Use at Baseline

Figure 2. After four years, 16 percent of patients who were taking opioids at study enrollment were taking opioids at time of study conclusion. Only 5 percent of patients who were opioid naive at the time of study enrollment and were treated with opioids during the study period were taking opioids at time of study conclusion.

Figure 1. There was no change in outcome between patients who were treated with opioids versus patients who were not treated with opioids over the four-year study period.

Source: Kris Radcliff, MD, Thomas Jefferson University Hospitals.

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8

JOINT REVISION

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11--800800--JEFFJEFF--NOW NOW || Jefferson.edu/OrthopedicJefferson.edu/Orthopedic || transfers: 1 transfers: 1--800800--JEFFJEFF--121 121 || physician referrals: 215-503-8888 physician referrals: 215-503-8888 9

At Jefferson, physicians continually explore ways to refine surgical techniques for primary

and revision total joint arthroplasty (TJA) and challenge conventional thinking on how best

to achieve outstanding outcomes for patients.

Through the collective experience of our orthopaedic specialists, more than 2,500 TJA

surgeries were performed in 2014, a number that speaks to the outstanding reputation of the

hip and knee team. In addition to their clinical work, Jefferson hip and knee specialists made

significant contributions to the surgical literature by expanding knowledge on the prevention

of pulmonary emboli, the use of urinary catheters with spinal anesthesia and identification of

periprosthetic joint infection using novel biomarkers. Here is a look at that research:

Symptomatic Pulmonary Embolus After Joint Arthroplasty: Stratification of Risk FactorsProphylaxis for pulmonary embolism (PE) after total joint arthroplasty (TJA) presents the clinical

dilemma of balancing the risk of postoperative thrombotic risk and anticoagulation-related

complications such as bleeding, hematoma formation and infection. It would be helpful to have

an evidence-based preoperative risk stratification system in place to evaluate whether patients

undergoing TJA are at increased risk for thrombosis or bleeding so that prophylaxis therapy could

be better tailored to an individual’s needs.

To identify what specific factors put patients at risk for PE, Jefferson researchers, headed by

Javad Parvizi, MD, conducted a retrospective review of 26,391 primary and revision TJAs

performed at the hospital between January 2000 and April 2011 and included in an internal

electronic database. Of those, 24,567 patients received warfarin prophylaxis for six weeks

and 1,824 received 325 mg. aspirin twice daily.

SERVICESSERVICES•• Anterior-approach total Anterior-approach total

hip replacementhip replacement

•• Minimally invasive hip and Minimally invasive hip and

knee replacementknee replacement

•• Custom knee replacementCustom knee replacement

•• Adult joint reconstructionAdult joint reconstruction

•• Hip resurfacingHip resurfacing

•• Partial knee replacementPartial knee replacement

•• Treatment of hip and knee Treatment of hip and knee

disorders in young adultsdisorders in young adults

•• Rapid-recovery surgeryRapid-recovery surgery

•• Computer-assisted surgeryComputer-assisted surgery

•• Pelvic reconstructionPelvic reconstruction

•• Pelvic osteotomy and Pelvic osteotomy and

hip-impingement surgeryhip-impingement surgery

•• Joint preservation Joint preservation

proceduresprocedures

JEFFERSON’S ORTHOPAEDIC SPECIALISTS HELP SET

STANDARDS OF CARE FOR PATIENTS UNDERGOING

HIP OR KNEE ARTHROPLASTY.

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10 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

Among the overall findings:

• The overall risk of postoperative symptomatic PE after

primary and revision TJA was 1.1 percent.

• The risk of fatal PE was 0.02 percent.

• Patients who were obese, (a Body Mass Index (BMI)>

30 Kg/m2), underdoing knee procedures, had multiple

medical comorbidities as reflected in an elevated score

on the Charlson Comorbidity Index, or had chronic

pulmonary disease, atrial fibrillation, anemia,

depression or postoperative deep vein thrombosis

were at greater risk of developing a postoperative PE.

“Although the goal of our study was to identify risk

factors associated with postoperative symptomatic PE

development in patients undergoing TJA, the ultimate

purpose of this study is to use this information in making

clinical choices regarding thromboprophylaxis,” the

researchers reported.

Based on their analysis, they developed a classification

system of low, medium and high risk. (See p. 10 and 11)

“The risk stratification system has been further studied

for validation by using the National Inpatient Sample

database,” Dr. Parvizi said, “and it has been adopted for

use at Jefferson.” The research team also is developing a

mobile application that doctors everywhere could use to

rank their patient’s risk for PE prior to surgery as a means

to determine the best anticoagulation prophylaxis.

Aspirin: An Alternative for Pulmonary Embolism Prophylaxis after Arthroplasty?It is not clear what drug is most effective in preventing

venous thromboembolism (VTE) following TJA. Both

warfarin and aspirin are used, but the debate over how

best to prevent embolism while minimizing bleeding

remains unresolved. Even though morbidity and

mortality associated with PE have decreased dramatically

in recent years, orthopaedic surgeons still worry about

the risk of PE.

To gain insight into the issue, Jefferson researchers

utilized their database to review information on 28,923

patients who underwent either primary or revision

arthroplasty at Jefferson from January 2000 to June

2012 and who had been given either aspirin (325 mg;

twice daily, 2,800 patients) or warfarin (dosing varied,

26,123 patients) prophylaxis.

JOINT REVISION

6,000 7,000 8,000 9,000 10,000 11,000

YTD 2014 9,174

YTD 2013 6,775

TOTAL 2013 10,849

Surgery VolumeSource: Jefferson internal data

Calendar YTD through September

Risk Factor Points P-Value

PULMONARY EMBOLISM (PE) RISK STRATIFICATION CRITERIA

Knee Surgery 5 <0.001

Charlson Comorbidity Index (CCI) 1xCCI 0.001

Atrial Fibrillation 4 <0.001

Postoperative DVT 14 <0.001

Chronic Obstructive Pulmonary Disease 2 0.006

Anemia 2 <0.001

Depression 2 0.012

Body Mass Index (BMI)

≤ 25 0 reference

25 to 30 1 0.035

> 30 2 <0.001

Source: Javad Parvizi, MD, Thomas Jefferson University Hospitals.

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Source: Javad Parvizi, MD, Thomas Jefferson University Hospitals.

Low Risk category defined as <7 points using our stratification scale

• Cumulative risk of PE in this group = 0.35 percent

• 13,324 (50.4 percent) of our TJA patients fell into this low risk group

• Accounts for 47 (16.7 percent) of the total PEs in our cohort

Medium Risk category defined as 7–15 points using our stratification scale

• Cumulative risk of PE in this group = 1.4 percent

• 12,474 (47.3 percent) of our TJA patients fell into this medium risk group

• Accounts for 179 (63.7 percent) of the total PEs in our cohort

High Risk category Defined as >15 points using our stratification scale

• Cumulative risk of PE in this group = 9.3 percent

• 593 (2.3 percent) of our TJA patients fell into this high risk group

• Accounts for 55 (19.6 percent) of the total PEs in our cohort

Pulmonary Embolism Risk Stratification Scale

0 0% 743 0

1 0% 1423 0

2 0.3% 2382 7

3 0.3% 2866 10

4 0.3% 2534 7

5 0.6% 1709 11

6 0.7% 1667 12

Total Score % Risk of PECumulative Risk in Each Group Patients

Patients in Risk Group (% of total) PEs

PEs in Each Risk Group (% of total)

LOW RISK PE CATEGORY: <7 POINTS

0.35% 13,324 (50.4%)

47 (16.7%)

7 1.1% 2094 22

8 1.2% 2847 34

9 1.3% 2934 37

10 1.6% 2062 34

11 1.6% 1048 17

12 2.6% 545 14

13 2.4% 373 9

14 1.6% 318 5

15 2.8% 253 7

Total Score % Risk of PECumulative Risk in Each Group Patients

Patients in Risk Group (% of total) PEs

PEs in Each Risk Group (% of total)

MEDIUM RISK PE CATEGORY: 7–15 POINTS

1.4% 12,474 (47.3%)

179 (63.7%)

16 4.3% 187 8

17 5.8% 138 8

18 1.8% 56 1

19 5.0% 20 1

20 4.5% 22 1

21 22.2% 27 6

22 23.3% 30 7

23 12.1% 33 4

24 21.6% 37 8

25 23.8% 21 5

26 28.6% 22 6

Total Score % Risk of PECumulative Risk in Each Group Patients

Patients in Risk Group (% of total) PEs

PEs in Each Risk Group (% of total)

HIGH RISK PE CATEGORY: >15 POINTS

9.3% 593 (2.3%)

55 (19.6%)

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The study, published in Clinical Orthopaedics and

Related Research, found that:

• The overall symptomatic PE rate was lower in patients

receiving aspirin therapy (0.14 percent) than in patients

receiving warfarin (1.07 percent).

• The rate of symptomatic DVT was 0.29 percent in

the aspirin group, compared to 0.99 percent in the

warfarin group.

• Patients who received aspirin had shorter hospital stays

on average — 2.48 days versus 4.08 days.

• While bleeding and infection rates did not

significantly differ between the two groups, the

incidence of wound-related problems was lower

when aspirin was used.

The researchers concluded that for many TJA patients,

aspirin can serve as an effective and safe alternative to

warfarin, which can be difficult to dose.

“The clinical success of less aggressive protocols in

conjunction with an increasing number of young,

healthy patients who are undergoing hip and knee

arthroplasties seem to indicate that aspirin can be an

adequate method of chemical anticoagulation in

selected patients after orthopaedic surgeries,” the

researchers reported. They noted that aspirin “is well

tolerated, inexpensive and easy to administer.”

Based on the study results, Jefferson hip and knee

surgeons are now relying more on aspirin as the

preferred choice for thromboprophylaxis.

Spinal Anesthesia: Should Everyone Receive a Urinary Catheter?The use of neuraxial anesthesia, commonly employed

for elective joint arthroplasty, is considered to be an

indication for the use of an indwelling urinary catheter.

The rationale is that spinal anesthesia can result in the

loss of the ability to sense bladder distention, which can

lead to bladder dysfunction. While solving one problem,

however, catheters can cause other problems, including

urinary tract infection.

Currently there is no standard protocol for the

implementation and maintenance of indwelling

catheters for elective joint arthroplasty. But at many

institutions catheters are routinely used since reports

indicate that roughly one in five patients could have

problems with urinary retention.

Jefferson researchers set out to evaluate the usefulness

of indwelling catheters in preventing urinary retention by

randomly assigning 207 consecutive patients undergoing

total hip arthroplasty to either receive a urinary catheter

or not to receive a catheter but be monitored for urinary

retention. If needed, the group being monitored received

straight catheterization for up to two times prior to the

insertion of an indwelling catheter.

The study, published in The Journal of Bone and Joint

Surgery, found that:

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12 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

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• The rate of urinary retention was 9.6 percent

without the use of an indwelling catheter, a rate much

lower than previous reports in the literature.

• Nine patients in the non-catheter group and three in

the catheter group (following removal of the catheter)

required straight catheterization.

• Three patients in the catheter group and none in the

non-catheter group developed urinary tract infection.

“Patients undergoing total hip arthroplasty under

spinal anesthesia appear to be at low risk for urinary

retention,” the researchers, headed by William Hozack,

MD, wrote. “Thus, a routine indwelling catheter is not

required for such patients.”

The researchers said that further research could help

identify whether certain subsets of patients might benefit

from placement of a urinary catheter.

Based on the study findings, Jefferson joint surgeons no

longer routinely use urinary catheters in patients

receiving joint replacement under spinal anesthesia.

Diagnosing Perioprosthetic Joint Infection: Has the Era of the Biomarker Arrived?The diagnosis of perioprosthetic joint infection (PJI)

remains a serious clinical challenge. The diagnostic

difficulty is caused by a variety of factors — the absence

of clinical signs and symptoms, the relative lack of

accurate laboratory tests and difficulties in isolation of

pathogens by culture because of prior antibiotic therapy

and existence in a biofilm form.

The Musculoskeletal Infection Society (MSIS) recently

responded to this diagnostic difficulty by developing a

multi-prong definition for PJI. Jefferson researchers have

been studying whether biomarkers found in the synovial

fluid could have a role in diagnosis of PJI, perhaps

helping to identify cases promptly so that appropriate

treatments could be initiated.

To test the usefulness of 16 biomarkers, a research team

headed by Carl Deirmengian, MD, collected synovial

fluid from 95 patients who were being evaluated for a

revision hip or knee arthroplasty, including some patients

with systemic inflammatory disease and those already

taking antibiotics. They used the MSIS definition to

classify 29 PJIs and 66 aseptic joints. Synovial fluid

samples were then tested by immunoassay for 16

biomarkers. The biomarkers were evaluated for

sensitivity and specificity to determine if they were good

predictors of PJI. Among the results:

• Five biomarkers — including human alpha defensin 1-3,

Neutrophil elastase 2, bactericidal/permeability-

increasing protein, neutrophil gelatinase-associated

lipocalin, and lactoferrin — correctly predicted the MSIS

classification of all patients in the study with 100 percent

sensitivity and specificity for the diagnosis of PJI.

• Eight other biomarkers demonstrated excellent

diagnostic strength.

“Considering that these biomarkers match the results of

the more complex MSIS definition of PJI, we believe that

synovial fluid biomarkers can be a valuable addition to

the methods utilized for the diagnosis of infection,” the

researchers concluded.

Jefferson researchers have been studying the

biomarkers for 11 years. A commercial test for PJI called

Synovosure, which combines alpha defensin and

synovial C-reactive protein, is now being manufactured

by CD Diagnostics.

Based on study results, Jefferson hip and knee surgeons are now relying more on aspirin as the preferred choice for thromboprophylaxis.

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HAND AND WRIST

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SERVICESSERVICES•• Hand and wrist surgeryHand and wrist surgery

•• Hand and wrist arthroscopyHand and wrist arthroscopy

•• Upper-extremity surgeryUpper-extremity surgery

•• Microvascular surgeryMicrovascular surgery

•• Hand arthritis surgeryHand arthritis surgery

•• Brachial plexus reconstructionBrachial plexus reconstruction

•• Treatment of ligament and Treatment of ligament and

tendon disorders of the hand tendon disorders of the hand

and wristand wrist

•• Treatment of carpal and Treatment of carpal and

cubital tunnel syndromescubital tunnel syndromes

•• Treatment of Treatment of

Dupuytren’s diseaseDupuytren’s disease

•• Treatment of complex Treatment of complex

nerve conditionsnerve conditions

•• Treatment of hand and Treatment of hand and

wrist sports injurieswrist sports injuries

•• Joint reconstruction for Joint reconstruction for

thumb arthritisthumb arthritis

•• Minimally invasive nerve Minimally invasive nerve

surgerysurgery

•• Joint replacement for Joint replacement for

hand arthritishand arthritis

THE HAND IS A COMPLEX STRUCTURE INVOLVING A SYSTEM OF

MULTIPLE MOVING PARTS. IT IS ONE OF THE MOST INTRICATE AND

DELICATE PARTS OF THE BODY AND THE CENTER FOR ONE OF THE

BODY’S FIVE SENSES, TOUCH.

Successful treatment of injuries and disorders involving

the hand, wrist and forearm requires an understanding

of how the many ligaments, tendons, muscle, joints

and bones work together to provide good function

and flexibility. An injury to one part can affect the

working of the whole, causing pain and disability.

Jefferson’s Department of Orthopaedic Surgery

draws on the expertise of hand specialists from the

Philadelphia Hand Center at Jefferson and the

Rothman Institute at Jefferson. They are leaders in the

treatment of hand arthritis, sports injuries, complex

nerve conditions and carpal tunnel syndrome, to

name just a few of their specialty services. The hand

surgeons, working along with basic scientists, are also

widely published researchers on both the mechanics

and biology of hand disorders and injuries, furthering

the understanding of key issues such as scar

formation. They make frequent contributions to the

literature on best practices for the medical and surgical

management of patients, new surgical techniques and

the efficacy of new implant materials and designs.

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16 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

Here is a look at some of their recent research findings:

Distal Radius Volar Locking Plate Design and Associated Vulnerability of the Flexor Pollicis LongusThe treatment of distal radius fractures has evolved

considerably over the past decade because of

advancements in implant technology and surgical

techniques. Since its introduction in 2000, the volar

locking distal radius plate (VLP) has become the

workhorse for the treatment of unstable distal radius

fracture. However, despite its popularity, VLP fixation

predisposes patients to specific risks and complications,

including flexor pollicis longus (FPL) tendon rupture,

which occurs in about 2 percent of cases.

Jefferson researchers, A. Lee Osterman, MD, and

Sidney M. Jacoby, MD, conducted a morphometric

study to determine whether VLP design was a factor in

FPL injury. They dissected 10 frozen cadaver tissue

samples to identify the path of the FPL in relationship

to the distal radius at the watershed line. Five VLP

designs were then fixed to each specimen based on

their anatomic fit, and slid distally until the distal edge

of the plate reached the watershed line. Fluoroscopy

was used to evaluate the positioning of each plate.

The researchers also evaluated the shape of each of

the five plates, in particular thickness, to evaluate native

flexor tendon anatomy proximity.

“Despite optimal plate placement, various VLP designs

were observed to have prominent profiles volar to the

watershed line,” the researchers reported in Journal of

Hand Surgery (American Volume).

“These results raise concerns regarding impingement

between all of the analyzed VLP designs and the FPL,”

they reported. “This study may help guide both implant

design considerations and assist the surgeon in better

understanding implant morphology as it relates to

iatrogenic flexor tendon injury.”

Radiation Exposure to Hand Surgeons’ Hands: A Practical Comparison of Large and Mini C-Arm FluoroscopyIntraoperative imaging modalities are becoming an

important and more routine part of orthopaedic

practice. Surgeons now have access to both small and

large fluoroscopic units with various specifications and

functionality. Many hand surgeons have moved to the

use of a mini C-arm fluoroscopy unit for a variety of

reasons: the mini unit is easier to use in a smaller

anatomical region such as the hand; the surgeon can

operate the unit independently without the need for a

radiology technologist; it takes up less space in the

operating room; and it costs less than a larger unit.

There is debate, however, over whether the mini C-arm

offers an advantage over a larger unit in terms of radiation

exposure. Studies have shown that the mini C-arm

creates less scatter than the large C-arm with respect to

ionizing radiation, but it’s not clear whether the smaller

arm exposes the surgeon to more radiation because the

surgeon’s hand is close to the operating unit.

Jefferson researchers Charles Leinberry, MD, and

Asif Ilyas, MD, designed a study to compute radiation

exposure to hand surgeons’ hands with the large

C-arm unit versus the mini arm. Two hand surgeons

monitored radiation exposure to their hands with a ring

dosimeter over a 14-month period. A total of 160

consecutive cases were included in the analysis. One

surgeon performed 71 cases using the large C-arm unit

and the other surgeon performed 89 cases using the

mini unit. For each case, fluoroscopic time, the output

displayed by the unit, radiation by time, and ring

dosimeter absorptions were recorded and analyzed.

Among the findings:

• The median fluoroscopic time per case using the

large unit was 38 seconds, compared to 88 seconds

for the mini C-arm. The added time may be because

it took the surgeon more time to manipulate the

small arm compared to the large one.

• The median output of radiation displayed by the large

C-arm was 0.7 mGy/case, compared to 10.1 mGy/

case for the mini C-arm.

• With output as a product of time, the median

calculated values were 0.02 mGy/second for the

large C-arm group compared to 0.28 mGy/s for the

mini C-arm group.

HAND AND WRIST

6,000 7,000 8,000 9,000

YTD 2014 7,268

YTD 2013 6,634

TOTAL 2013 8,604

Surgery VolumeSource: Jefferson internal data

Calendar YTD through September

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• Cumulative ring dosimeter absorption to the

surgeon’s hands was 380 mrem for the 71 cases in

the large C-arm group versus 1,000 mrem for the 89

cases in the mini C-arm group.

“The mini C-arm unit delivered a greater radiation

exposure to the hands of the surgeon,” the researchers

concluded in a report in the Journal of Hand Surgery

(American Volume). “In our model, the use of the

mini C-arm resulted in more than a 10-fold increase

in the rate of output and approximately double

the dosimeter absorption to the surgeons’ hands

compared with the large C-arm.”

While the surgeons’ cumulative radiation exposure to

their hands remained well below the internationally

recommended maximum exposure level of 50,000

mrem to the extremities per year, the added exposure

that comes with the use of the mini C-arm for

fluoroscopy is worth considering, the researchers said.

“Surgeons should be aware of their hands’ locations

during fluoroscopy and take precautions to limit

fluoroscopic time and radiation exposure,” they

recommended.

Four-corner Arthrodesis with a Radiolucent Locking Dorsal Circular Plate: Technique and OutcomesScaphoid excision and four-corner arthrodesis (FCA)

is an acceptable motion sparing procedure used to

treat wrist arthritis. Fixation methods for the

procedure vary and include the use of K-wires, staples

and headless compression screws. Dorsal circular

plates were developed with the idea that they could

allow earlier range of motion while limiting

postoperative stiffness, but results have been

somewhat discouraging. More recently, locking dorsal

circular plates have come into use, and the Xpode®

cup is the first in the class to be composed of

radiolucent polyether-ether-ketone. The Xpode®

(made by TriMed Inc.) is designed to allow for more

accurate radiographic assessment of cup placement

intraoperatively as well as union postoperatively,

compared to stainless steel models. The new device

also provides elasticity similar to cortical bone.

To study the efficacy of the Xpode® cup for FCA,

Jefferson researchers, Sidney M. Jacoby, MD, and Mark

S. Rekant, MD, reviewed the cases of all patients who

underwent FCA with the device between January 1,

2008 and December 31, 2012. Twenty-six procedures

(24 patients) were identified, and the patients were

contacted and asked to return to the clinic for clinical

and radiographic follow up.

Among the findings, reported in Hand, were:

• One patient required full wrist fusion following the

initial procedure. Arthrodesis was successfully

achieved in 20 of the other 25 wrists (80 percent).

• Eleven patients (13 wrists) returned to the clinic for

follow-up at an average time of 28 months

postoperatively. For those patients, mean wrist

extension improved from 30 degrees to 47

degrees, and flexion decreased from 33 degrees

to 23 degrees.

• At follow up, the average grip strength was 77 percent

of the uninjured side.

• Patient-Rated Wrist Evaluation (PRWE) scores for pain

and function were 19.7 out of a possible 50 and

17.1/50 respectively.

Radiographs sequentially reveal increasing osseous fusion mass in the same patient over time (beginning with immediate post-operative image A through final follow up image D).

A

C

B

D

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18 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

• Five patients underwent additional operations (two

hardware removals, two contracture releases, and

one distal radial ulnar joint arthroplasty).

“The present study demonstrates an 80 percent

fusion rate following scaphoid excision and four-

corner arthrodesis using the Xpode® cup, as well as

acceptable pain and function outcomes at early

follow-up,” the researchers concluded. “As a salvage

procedure the Xpode® cup is a viable implant option

for degenerative and posttraumatic wrist disorders.”

Distal Interphalangeal Joint Bony Dimensions Related to Headless Compression Screw SizesDistal interphalangeal (DIP) joint arthrodesis using

headless compression screws has gained popularity

because of the screws’ ability to provide strong

compression, allow for early mobilization and avoid

the need for external hardware with its associated

potential complications. Although high rates of union

have been reported, these screw implants must be

sized appropriately to the bony anatomy to minimize

the risk of complications related to medullary reaming

or incompatibility of screw size.

Jefferson researchers headed by Kevin Lutksy, MD,

Jonas Matzon, MD, and Pedro Beredjiklian, MD,

conducted a study to determine the radiographic

dimensions of the DIP joint and to compare these

measurements with commonly used headless

compression screws. Using standard posteroanterior

and lateral radiographs of the hand, they measured

the dimensions of the distal and middle phalanges in

60 index, middle, ring and little fingers and compared

those measurements with the diameters and lengths

of 16 commercially available screws commonly used

for DIP joint arthrodesis. Percent compatibility and

risk factors for incompatibility were determined.

Among the findings, which were published in Journal

of Hand Surgery (American Volume), were:

• In general, commercially available screws were

too large in diameter given the anatomic diameters

of the DIP joint.

• The distal phalanx shaft as measured on the lateral

view was the narrowest determinant of fit.

• When the dimensions of all the fixation devices

were combined, screws were oversized relative

to the bony anatomy in 66 percent of index fingers,

53 percent of middle fingers, 49 percent of ring

fingers and 72 percent of little fingers. The

mismatch was greater in women than men.

• Only one of the compression screw types

(Acumed Acutrak Fusion) demonstrated a

compatibility rate greater than 90 percent for

the index and little fingers, respectively.

• There was a positive correlation between

greater patient height and good fit, a finding that

suggests that mismatch is more likely to occur in

shorter patients.

The researchers noted that there are few reports

in the literature of complications due to screw size

mismatch, but that doesn’t mean the problem is

insignificant. They said there may be some tolerance

for a size mismatch.

“Nevertheless, the small size of these bones,

narrow soft tissue envelope and close proximity of

the nailbed increase the possibility of screw-related

complications including iatrogenic fracture (and

potential loss of fixation), nail plate deformity, and

discomfort with tip pinch related to hardware

prominence,” they reported. “Therefore, ensuring

that the chosen screw will fit the anatomy is of

paramount importance.”

HAND AND WRIST

Pre and postoperative X-rays of a patient with end-stage arthritis of the distal interphalangeal joint of the finger treated with a fusion using a head- less compression screw.

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MUSCULOSKELETAL ONCOLOGY

20

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Tumors of the bone and soft tissue present not only

a tremendous oncologic challenge, but they also

require precise surgical attention in order to preserve

limbs and limb function.

The Center’s treatment team draws on the expertise of

both Jefferson’s Department of Orthopaedic Surgery

and the NCI-designated Sidney Kimmel Cancer Center

at Thomas Jefferson University. Patients with a primary

bone or soft tissue sarcoma or metastatic skeletal

disease require a multi-modality approach to treatment,

and the Center’s goal is to establish a treatment plan that

can evolve with the patient’s needs. Common types of

cancer frequently dealt with by the Center include

osteosarcoma, chondrosarcoma, Ewing sarcoma, as

well as all subtypes of soft tissue sarcoma.

The Center, under the direction of John A. Abraham,

MD, has a particular expertise in using computer-assisted

surgical navigation for resection and reconstruction of

malignant bone tumors, including those in difficult

locations such as the spine and pelvis.

THE SPECIALISTS AT THE JEFFERSON MUSCULOSKELETAL

ONCOLOGY CENTER ROUTINELY HANDLE SOME OF THE

RAREST AND MOST DIFFICULT TYPES OF CANCER.

SERVICESSERVICES•• Management of extremity Management of extremity

bone sarcomabone sarcoma

•• Management of extremity soft Management of extremity soft

tissue sarcomatissue sarcoma

•• Pelvis sarcoma resection, bone Pelvis sarcoma resection, bone

and soft tissueand soft tissue

•• Computer-navigated bone Computer-navigated bone

tumor resectiontumor resection

•• Treatment of benign bone Treatment of benign bone

tumorstumors

•• Treatment of benign soft Treatment of benign soft

tissue tumorstissue tumors

•• Management of skeletal Management of skeletal

metastatic diseasemetastatic disease

•• Management of spine lesions in Management of spine lesions in

conjunction with spine serviceconjunction with spine service

•• Subspecialty imaging reviewSubspecialty imaging review

•• Subspecialty pathology reviewSubspecialty pathology review

•• Complex joint reconstructionComplex joint reconstruction

•• Custom joint reconstructionCustom joint reconstruction

•• Acetabular revision joint Acetabular revision joint

proceduresprocedures

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22 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

The surgeons at the Musculokeletal Oncology Center

also focus on research to improve the diagnosis and

treatment of these rare and complex tumors. The

surgeons’ contributions to the literature through the

publications of original studies, review articles and case

reports are helping to advance care beyond Jefferson.

Here is some of their recently published research:

Resection of Soft Tissue Tumors Extending Through the Obturator RingSoft tissue sarcomas account for approximately

1 percent of adult malignancies, and of those, only

5 percent are located in the pelvis. These tumors

present a real challenge for clinicians. Pelvic soft tissue

sarcomas are difficult to detect because the pelvis can

be accommodating of large lesions, and often

symptoms don’t become apparent until tumors have

reached a considerable size. Compared with similar

tumors found in the extremities, pelvis soft tissue

sarcomas demonstrate a higher risk of recurrence,

metastatic disease at presentation, extensive size, early

local invasion and poorer prognosis. Surgical resection

of pelvic tumors is extremely difficult because of

proximity to critical organs, nerves and blood vessels.

A subset of pelvic soft tissue sarcoma that is particularly

problematic involves tumors that extend through the

obturator ring. There is very little information available in

the literature on how best to excise them.

A surgical team led by Dr. Abraham presented details on

two cases in which a soft tissue sarcoma extended

through the obturator ring. In one case, a 58-year-old

woman presented with pain and swelling in the left leg.

In the other case, a 60-year-old woman presented with

painless swelling of the right thigh. In each case, a

diagnostic workup revealed a malignant lesion extending

through the obturator ring. It is difficult to resect tumors

in this location because there is no good way to pull the

tumor out of the obturator ring of the pelvis without

contaminating the surgical field with tumor.

Dr. Abraham, in detailing his surgical approach for the

two cases, said that the goal was “to achieve a negative

margin resection while preserving limb function by

resecting the obturator ring en bloc with the tumor.”

A modified type III internal hemipelvectomy was used to

excise the tumor and obturator ring in entirety as one

large specimen, the team reported. Both patients

remained disease-free for two years postoperatively.

“Although the sample size is too small to draw

conclusions, the cases described in this study offer a

potential approach to tumors found in this location,”

the researchers wrote.

Mesh Reconstruction of the Inguinal Ligament with Bone Anchors Following Radical Oncologic Excision: A Case SeriesIn a related study, Jefferson surgeons headed by

Dr. Abraham reported on a case series involving six

patients who underwent reconstructive surgery

following radical excision of the obturator ring utilizing

Dr. Abraham’s technique. The researchers reported in

the journal Hernia on a technique they developed to

reconstruct the inguinal ligament and abdominal wall

using bioprosthetic mesh and bone anchors.

Six consecutive patients operated on using the described

technique were followed to determine their level of pain

and mobility six months postoperatively. The study found:

• Four of six patients were able to mobilize without a

cane, crutch, wheelchair or other assistive device.

• Four of six patients were off narcotics and had no

abdominal symptoms.

• CT scans did not reveal any evidence of groin hernia in

any of the patients.

The authors said their technique using bioprosthetic

mesh and bone anchors provides the first description of

an option for inguinal reconstruction following radical

excision of the obturator ring.

MUSCULOSKELETAL ONCOLOGY

200 250 300 350 400

YTD 2014 326

YTD 2013 307

TOTAL 2013 410

Surgery VolumeSource: Jefferson internal data

Calendar YTD through September

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Upper Extremity Considerations for Oncologic SurgeryPrimary bone and soft tissue tumors of the upper

extremities are extremely rare, and they are particularly

challenging clinically because treatment to eradicate the

cancer must coincide with efforts to preserve function of

a shoulder, arm or hand.

It is imperative for clinicians to have a systematic

approach to the diagnosis and treatment of bone and

soft tissue tumors to maximize patient outcome. With

advances in chemotherapy, radiotherapy, imaging and

surgical reconstructive options, limb salvage surgery is

estimated to be feasible in 95 percent of extremity bone

or soft tissue sarcomas.

In an article published in Orthopaedic Clinics of North

America, John A. Abraham, MD, Director of the

Musculoskeletal Oncology Center and Assistant Professor

of Orthopaedic Surgery and Radiation Oncology, Sidney

Kimmel Medical College at Thomas Jefferson University,

and Justin C. Wong, MD, of the Department of

Orthopaedic Surgery at Thomas Jefferson University,

provided a detailed guide for clinicians on the diagnosis

and management of upper extremity tumors. Among

their diagnostic observations and recommendations:

• Nearly 30 percent of soft tissue sarcomas occur in the

upper extremity. Patients with a soft tissue tumor often

present with a painless mass. A patient with a bone

tumor may feel pain.

• Elements of a patient’s history that should warrant a

higher level of suspicion for a malignancy include change

in the size of a mass, presence of night pain and, in some

cases, symptoms such as fever, chills and night sweats.

• Diagnostic imaging is a crucial component of the

workup and should proceed in an organized fashion.

Initial imaging often includes radiographs in

orthogonal planes to localize and characterize the

lesion. Ultrasound may help differentiate between

a tumor and a cyst, and cross sectional imaging with

CT or MRI can provide crucial information regarding

size, tissue characteristics and anatomic relationship

to other structures.

• In aggressive appearing lesions and most soft

tissue masses, a histologic specimen should be

obtained for diagnosis. Soft tissue masses that are

larger than 5 cm or deep to the investing fascia

have an increased chance of being sarcoma and

should be referred to an orthopaedic surgeon

oncologist before obtaining biopsy.

• Current grading and staging systems for

musculoskeletal tumors are designed to guide

treatment, provide diagnostic information for

patients, and standardize research. A staging system

for malignant bone tumors has been devised by

the Musculoskeletal Tumor Society. A useful system

for staging soft tissue sarcomas has been devised by

the American Joint Committee on Cancer. Among

their surgical recommendations:

• The primary goal of any surgical intervention for

musculoskeletal tumors is local control of the cancer.

• Familiarity with nerve and vessel reconstruction, tendon

transfer, soft tissue coverage and endoprosthetic

reconstructions that maximize function is critical for the

surgeon undertaking treatment of oncologic problems

in the upper extremity.

It is imperative for clinicians to have a systematic approach to the diagnosis and treatment of bone and soft tissue tumors to maximize patient outcome. With advances in chemotherapy, radiotherapy, imaging and surgical reconstructive options, limb salvage surgery is estimated to be feasible in 95 percent of extremity bone or soft tissue sarcomas.

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TRAUMA

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Patients treated at Jefferson for traumatic injury benefit from its designation as a Level 1

Trauma Center. Specialists in orthopaedic trauma are well versed in the care of complex,

limb-threatening musculoskeletal injuries, as well as more routine fractures that can cause

life-altering disability if not optimally treated.

In addition to providing round-the-clock staffing for trauma, the orthopaedic trauma team

focuses on research that is aimed at both improved care and prevention of orthopaedic injuries.

One ongoing area of research interest is osteoporosis-related hip fractures — a problem that is

likely to become even more pressing as the population ages.

Here is a look at a recently published study.

Association of Atypical Femur Fractures in Patients on Bisphosphonates with Varus Hip GeometryAn estimated 10 million Americans have osteoporosis and over 1.5 million fractures a year are

attributed to the disease. The incidence of osteoporosis is expected to double or triple in the next

quarter of a century as the elderly population increases.

The first commercially available bisphosphonate approved for the treatment of osteoporosis was

introduced in the U.S. in 1995, and the drugs are now used by more than four million women in

this country. While the osteoporosis drugs have been credited with lowering the rate of hip

fractures among women, there is also evidence that the incidence of “atypical” femur fractures

are increasing in women who take the drugs for a prolonged period of time.

SERVICES• Treatment of fractures,

both simple and complex,

using both nonoperative

and operative methods.

Includes articular

fractures and pelvic/

acetabular fractures

• Assessment and treatment

of problem fractures,

those that have gone on

to malunion or nonunion

• Functional treatment

of fragility fractures of

the elderly

• Treatment of post

traumatic bone infections

IN ADDITION TO PROVIDING ROUND-THE-CLOCK STAFFING FOR

TRAUMA, THE ORTHOPAEDIC TRAUMA TEAM FOCUSES ON RESEARCH

THAT IS AIMED AT BOTH IMPROVED CARE AND PREVENTION OF

ORTHOPAEDIC INJURIES

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26 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

The cause of these fractures is unknown and likely

multifactorial. Atypical characteristics of these fractures

include fracture obliquity (transverse or short oblique),

location in the femur (subtrochanteric or diaphyseal) and

a very low energy mechanism (fall from ground level

height or less.) James Krieg, MD, now Director of

Orthopaedic Trauma at Jefferson, designed and directed

a study to evaluate proximal femoral geometry in

patients with primary osteoporosis on chronic

bisphosphonate therapy.

The study, published in Journal of Bone and Joint

Surgery, was a multi-center retrospective case-control

study conducted by Dr. Kreig before his appointment at

Jefferson. It included 111 patients who had been treated

for a complete or incomplete atypical femoral shaft

fracture while on bisphosphonate therapy and a control

group of 33 patients who had documented use of the

drug for primary osteoarthritis but no history of fractures.

The researchers reviewed radiographs to take

measurements. The femoral neck-shaft angle (NSA)

and the tip of the greater trochanter to the height

of the center of the femoral head (THC) distances

were measured.

The study found anatomical differences between patients

who had a fracture and those who didn’t. Specifically:

• There was a statistically significant difference in the

NSA of patients with atypical femur fractures compared

to the controls (129.9 degrees on average compared to

133.8 degrees).

• Fifty-three patients (47.7 percent) in the fracture group

had an NSA lower than the lowest angle in the control

group (128 degrees).

“Patients on chronic bisphosphonates who presented

with atypical fractures had more varus proximal femoral

geometry than those without fractures,” the researchers

concluded. “Although no causative effect can be

determined, the presence of varus geometry may help

better identify patients at risk for fractures after long-

term bisphosphonate use.”

The researchers noted that while more research is

needed to confirm the study’s findings, it would be easy

to use X-rays to identify patients who may be at

particular risk for fractures while taking bisphosphonates

and then counsel them on symptoms.

“While this is likely only one piece of the picture, we feel

our findings add a useful clinical marker that could help

identify an ‘at risk’ subset of this population,” the

researchers said.

TRAUMA

An estimated 10 million Americans have osteoporosis and over 1.5 million fractures a year are attributed to the disease. The incidence of osteoporosis is expected to double or triple in the next quarter of a century as the elderly population increases.

100 200 300 400

YTD 2014 366

YTD 2013 119

TOTAL 2013 194

Surgery VolumeSource: Jefferson internal data

Calendar YTD through September

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This patient has an “atypical” femur fracture. It happened with very minor trauma. Once the fracture was treated surgically, she went on to healing and return of function.

This patient had the radiographic and clinical changes that can precede an atypical fracture. By treating it prophylactically, surgeons were able to help her maintain function aftera brief recovery, without having to experience a fracture.

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28 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

Funded Clinical Trial Investigator(s)

Prospective Post Market Clinical Follow-Up Study of the Zimmer Trabecular Metal Humeral

Stem. Zimmer (04/05/2012–ongoing)

Joseph A. Abboud, MD

Retrospective, Post-Market, Clinical and Radiographic Follow-Up Study of the DePuy Delta

Xtend Reverse Shoulder System. DePuy Synthes (9/24/2013–ongoing)

Joseph A. Abboud, MD,

Gerald R. Williams, Jr., MD

A Phase II Randomized, Double-Blind, Placebo Controlled Study to Assess Safety,

Tolerability and Effect on Tumor Size of MCS110 in Patients with Pigmented Villonodular

Synovitis (PVNS). Novartis (10/1/2013–ongoing)

John A. Abraham, MD

Treatment of Plantar Fasciitis with Xeomin: A Randomized, Placebo-Controlled,

Double-Blinded, Prospective Study. Merz (4/05/2012–ongoing)

Jamal Ahmad, MD

A Prospective, Randomized Clinical Investigation of the Cervitech, Inc. Porous Coated

Motion Artificial Disc for Stabilization of the Cervical Spine between C3-C4 and C7-T1.

NuVasive (02/03/2005–ongoing)

Todd J. Albert, MD,

Alan S. Hilibrand, MD,

Ashwini D. Sharan, MD

A Multicenter Prospective Randomized Controlled Clinical Trial Comparing the Safety and

Effectiveness of PRODISC-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in

the Treatment of Symptomatic Cervical Disc Disease (SCDD)–Non randomized PRODISC-C

continued access arm. Synthes Spine (04/28/2005–ongoing)

D. Greg Anderson, MD,

Todd J. Albert, MD,

Alexander R. Vaccaro, MD, PhD

A Prospective, Randomized, Double Blind, Controlled Investigation Evaluating the Intracept

Intraosseous Nerve Ablation System for the Reduction of Pain in Patients with Chronic Axial

Low Back Pain. Relievant (04/2012–ongoing)

D. Greg Anderson, MD,

Kris E. Radcliff, MD

Post-Market Clinical Follow-Up Study of the Zimmer Vivacit-E Highly Crosslinked

Polyethylene Liner Used with the Continuum Acetabular Shell. Zimmer (10/1/2013–ongoing)

William V. Arnold, MD, PhD,

Javad Parvizi, MD

Prospective Post-Market Clinical Follow-Up of the Zimmer Trabecular Metal Reverse

Shoulder System. Zimmer (08/2011–ongoing)

Luke S. Austin, MD,

Matthew D. Pepe, MD,

Bradford S. Tucker, MD

Prospective Clinical Evaluation Treating Subchondral Bone Marrow Lesions with

Subchondroplasty for Pain Relief. Knee Creations LLC (3/15/2012–ongoing)

Steven B. Cohen, MD

Trabecular Metal Femoral Hip Stem Used within the Zimmer Hip Registry. Zimmer

(02/09/2012–ongoing)

Carl Deirmengian, MD

Prospective Post-Market Clinical Follow-Up of the Zimmer Trabecular Metal Reverse Shoulder

System. Zimmer (08/23/2011–ongoing)

Charles L. Getz, MD,

Matthew L. Ramsey, MD

Ascension Radial Head. Integra Life Sciences (09/2012–ongoing) Charles L. Getz, MD, Matthew L. Ramsey, MD, Joseph A. Abboud, MD

Muticenter Trial of the Sidus Stem Free Shoulder Arthroplasty System. Zimmer

(7/18/2013–ongoing)

Charles L. Getz, MD,

Matthew L. Ramsey, MD,

Joseph A. Abboud, MD

Post-Market Study of the Stryker Orthopaedics Triathlon TS Total Knee System. Stryker Orthopaedics (4/1/2012–ongoing)

Fabio R. Orozco, MD, Alvin C. Ong, MD

Persona Outcomes Knee Study (POLAR). Zimmer (3/1/2013–ongoing) Matthew S. Austin, MD

Skelkast Surpass Post-Approval Active Surveillance. Skelkast (10/2012–ongoing) Peter F. Sharkey, MD,

Rob Good, MD

ONGOING CLINICAL TRIALSONGOING CLINICAL TRIALS

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Funded Clinical Trial Investigator(s)

Retrieval of Discarded Surgical Tissue. National Disease Registry Institute

(1/12/2004–6/30/2013)

Javad Parvizi, MD, Peter F.

Sharkey, MD, James J. Purtill, MD,

William J. Hozack, MD,

Richard H. Rothman, MD, PhD

Multicenter Trial of the Continuum Ceramic Bearing System in Total Hip Arthroplasty.

Zimmer (08/05/2010–ongoing)

Javad Parvizi, MD, William J.

Hozack, MD, Matthew S.

Austin, MD

American Joint Replacement Registry (12/23/2010–ongoing) Javad Parvizi, MD

A Phase II Study to Determine the Efficacy and Safety of Allogeneic Human

Chrondrocytes Expressing TGF-ß1 in Patients with Grade 3 Chronic Degenerative

Joint Disease of the Knee (09/01/2011–ongoing)

Javad Parvizi, MD,

Marc I. Harwood, MD,

Peter C. Vitanzo, Jr., MD

Evaluation of In-vivo Wear of Ceramic Femoral Head Against Highly Cross-Linked Polyethylene: A Comparative Study. Ceramtec (11/2011–ongoing)

Javad Parvizi, MD

A Post-Market, Prospective, Single Center, Randomized, Pilot-Phase Investigation of the Effects of PlasmaBlade™ Dissection and Coagulation on Soft Tissue Inflammation Parameters Following Total Knee Arthroplasty. Medtronic (5/17/2013–ongoing)

Javad Parvizi, MD

Evaluation of the Clinical Utility of the Cobas® MRSA/SA Test for Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus from Nasal Swabs. Roche Molecular Systems (7/1/2013–ongoing)

Javad Parvizi, MD

A Prospective, Randomized, Controlled, Multicenter, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment Injectable Bone Graft Compared to Autologous Bone Graft as Bone Regeneration Device in Hindfoot Fusions. BioMimetic (4/7/2011–ongoing)

Steven M. Raikin, MD

Characterization of Bone Marrow Lesions in Retrieved Tibial Plateaus. Knee Creations LLC

(8/3/2011–ongoing)

Peter F. Sharkey, MD

Efficacy of Riluzole in Patients with Cervical Spondylotic Myelopathy Undergoing

Surgical Treatment, A Randomized, Double-Blind Placebo-Controlled, Multicenter Study.

AOSpine North America (02/16/2012–ongoing)

Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, Alan S. Hilibrand, MD, D. Greg Anderson, MD, Jeffrey A. Rihn, MD, Kris E. Radcliff, MD

Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC). Quality of Life and Cost-Effectiveness Outcomes. AOSpine North America (02/14/2008–ongoing)

Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, Alan S. Hilibrand, MD, D. Greg Anderson, MD, Jeffrey A. Rihn, MD, Kris E. Radcliff, MD

An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation Investigational Plan. Cerapedics (06/07/2007–ongoing)

Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, James S. Harrop, MD, Ashwini D. Sharan, MD, Srinivas Prasad, MD, Jack Jallo, MD, PhD, FACS

Addendum to Investigational Plan 1003 Version 5.3 IDE Protocol G050178: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation. Cerapedics (03/11/2010–ongoing)

Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, James S. Harrop, MD

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30 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research

Funded Clinical Trial Investigator(s)

Prospective, Multicenter Single Arm Study to Assess Clinical Outcomes in Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement. Tornier/LifeCell (02/18/2010–ongoing)

Gerald R. Williams, MD

Bacterial colonization with and without iodophor-impregnated adhesive drapes in hip surgery: a prospective, randomized, multicenter trial. 3M Corporation (06/2014–present)

Javad Parvizi, MD, Antonia Chen, MD

Retrospective and Prospective Data Collection Study of the TITAN Modular Total Shoulder

System (TSS). Integra (08/2014–present)

Surena Namdari, MD, Matthew

Ramsey, MD, Joseph Abboud,

MD, Mark Lazarus, MD, Gerald

Williams, MD, Charles Getz, MD

A Pivotal, Multicenter, Double-Blind Study of the Safety and Effectiveness of

Synvisc-One® (hylan G-F 20) in Patients with Mild to Moderate Primary Osteoarthritis

of the Hip. Genzyme (06/2014–present)

Javad Parvizi, MD,

Barry Kenneally, MD,

Mitch Freedman, MD,

Alvin Ong, MD,

Fabio Orozco, MD

Prospective Post Market Clinical Follow-Up Study of the Zimmer® Trabecular Metal™

Total Ankle System. Zimmer (08/2014–present)

Steven Raikin, MD,

David Pedowitz, MD

The Influence of a Natural Anti-Inflammatory Product on Levels of Inflammatory Markers in

Cases of Osteoarthritis of the Knee. PRN Neutriceuticals (03/2013–present)

Peter Sharkey, MD,

Javad Parvizi, MD

A Multi-Centre 2x2 Factorial Randomized Trial Comparing Sliding Hip Screws versus

Cancellous Screws AND Vitamin D versus Placebo on Patient Important Outcomes and

Quality of Life in the Treatment of Young Adult (18-60) Femoral Neck Fractures.

McMaster University (08/2014–present).

James Krieg, MD, Asif Ilyas, MD,

Gregory Deirmegian, MD,

Sommer Hammoud, MD,

John A. Abraham, MD,

Jamal Ahmad, MD

Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): A Multi-Center Randomized

Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor

Resections with Endoprosthetic Replacements. McMaster University (02/2014–present)

John A. Abraham, MD,

Barry Kenneally, MD

Multi-Institutional Trial using Qualitative CT Scan for Determining Pathologic Fracture Risk

in Skeletal Malignancy. Musculoskeletal Tumor Society (8/2014–ongoing)

John A. Abraham, MD,

Barry Kennealy, MD

Basal Joint Arthroplasty Pain Management – Prospective Comparative Study.

Pacira (08/2013–present)

Fred Liss, MD, Asif Ilyas, MD,

Charles Leinberry, MD,

Pedro Beredjiklian, MD

Triathlon Tritanium Knee Outcomes Study. Stryker (04/2014–present) Fabio Orozco, MD,

Alvin Ong, MD,

Zachary Post, MD

Post Market Study of the Stryker Orthopaedics Triathlon PKR Knee System.

Stryker (11/2013–Present)

Fabio Orozco, MD,

Alvin Ong, MD,

Zachary Post, MD

Comparing Pain Relief between Exparel® Injection Versus On-Q Catheter as the

Postsurgical Analgesia Following Total Knee Arthroplasty (TKA). Sharpe-Strumia Research

Foundation (07/01/2013–ongoing)

Eric B. Smith, MD,

Jess H. Lonner, MD,

Peter F. Sharkey, MD

Outcomes of Patients following Primary Total Knee Replacement. Stelkast (6/7/2013–ongoing) Peter F. Sharkey, MD

JG

14

-23

05

ONGOING CLINICAL TRIALS

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T h e A r t o f

O r t h o p a e d i c s

Thomas Jefferson University Hospitals

Department of Orthopaedic Surgery

Philadelphia, PA 19107

Patient Appointments: 1-800-JEFF-NOW

Patient Transfers: 1-800-JEFF-121

Physician Referrals: 215-503-8888

Jefferson.edu/Orthopedic

G14-19431_OrthoCOV.indd 1 12/22/14 9:34 AM