the art of orthopaedics
TRANSCRIPT
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T h e A r t o f
O r t h o p a e d i c s
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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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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.
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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
just
ed M
ean
Di�
eren
t fr
om
Bas
elin
e
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
just
ed M
ean
Di�
eren
t fr
om
Bas
elin
e
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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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:
JOINT REVISION
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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14
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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24
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
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