Archive | April 2021

What’s New in Sports Medicine 2021

Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 14 subspecialties. Click here for a collection of all such OrthoBuzz Guest Editorial summaries.

This month, co-author Rachel M. Frank, MD summarizes the 5 most compelling findings from the >30 studies highlighted in the April 21, 2021 “What’s New in Sports Medicine.”

Anterior Cruciate Ligament (ACL)

–Two-year results from the STABILITY randomized controlled trial (RCT)1 comparing single-bundle, hamstring-autograft ACL reconstruction with or without lateral extra-articular tenodesis demonstrated a

4% graft failure in the tenodesis group versus 11% in the non-tenodesis group. Both groups had similar levels of sports activity at 2 years.

Meniscus

–A matched cohort comparison of 45 posterior medial meniscal root tears2 treated either nonoperatively, with partial meniscectomy, or with root repair found the following at a mean of 74 months:

  • No significant between-group differences in patient-reported outcomes (IKDC and Tegner scores)
  • Progression to arthroplasty in 60% of those who underwent partial meniscectomy, 27% of those treated nonoperatively, and 0% of those who underwent root repair
  • Less arthritic progression on radiographs in the root-repair group relative to the other 2 groups

Rotator Cuff

A multicenter Level-II study compared 96 patients with a rotator cuff tear who underwent nonoperative treatment with 73 similar patients who underwent a surgical procedure. At approximately 3 months, patients in the nonoperative group had significantly better outcomes, but after 1 to 2 years, surgical patients did better in terms of ASES and SPADI scores.

Hip Preservation

–A meta-analysis of 3 RCTs (n=650 patients)3 comparing physical therapy with hip arthroscopy for treating femoroacetabular impingement found the following:

  • Greater improvement in the arthroscopy group (as measured with the International Hip Outcome Tool-33) at 10 months
  • No between-group differences in 1 of the 3 RCTs at 1 or 2 years when the Hip Outcome Score-ADL and -Sports scales were used

The authors concluded that “hip arthroscopy had significantly superior short-term outcomes.”

Long Head of the Biceps Tendon

–A prospective RCT4 compared biceps tenodesis with biceps tenotomy in >100 patients with pathology of the long head of the biceps tendon. At the 2-year follow-up, the authors found no between-group differences in cramping, elbow flexion strength, or supination strength. The only significant difference was the incidence of a cosmetic Popeye deformity, which was associated with a 3.5 times higher risk after tenotomy.

References

  1. Getgood AMJ, et al. for the STABILITY Study Group. Lateral extra-articular tenodesis reduces failure of hamstring tendon autograft anterior cruciate ligament reconstruction: 2-year outcomes from the STABILITY study randomized clinical trial. Am J Sports Med.2020 Feb;48(2):285-97. Epub 2020 Jan 15.
  2. Bernard CD, Kennedy NI, Tagliero AJ, Camp CL, Saris DBF, Levy BA, Stuart MJ, Krych AJ. Medial meniscus posterior root tear treatment: a matched cohort comparison of nonoperative management, partial meniscectomy, and repair. Am J Sports Med.2020 Jan;48(1):128-32. Epub 2019 Nov 25.
  3. Dwyer T, Whelan D, Shah PS, Ajrawat P, Hoit G, Chahal J. Operative versus nonoperative treatment of femoroacetabular impingement syndrome: a meta-analysis of short-term outcomes. 2020 Jan;36(1):263-73.
  4. MacDonald P, Verhulst F, McRae S, Old J, Stranges G, Dubberley J, Mascarenhas R, Koenig J, Leiter J, Nassar M, Lapner P. Biceps tenodesis versus tenotomy in the treatment of lesions of the long head of the biceps tendon in patients undergoing arthroscopic shoulder surgery: a prospective double-blinded randomized controlled trial. Am J Sports Med.2020 May;48(6):1439-49. Epub 2020 Mar 30.

Home in on Bone Health in Patients with Fragility Fractures

AOA_OwnTheBone_Logo_12.17_Final_RGB-stackedOrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from James Blair, MD, in response to a recent edition of the OrthoJOE podcast.

Geriatric hip fractures are among the fastest growing subset of injuries that orthopaedic surgeons treat. Often these injuries are the first objective signs of osteoporosis. While the surgical treatment of these fractures continues to improve, orthopaedic surgeons may be neglecting their role in triggering investigations into the underlying bone health of these patients.

A recent insurance database analysis by Sara Cromer, MD, presented at the Endocrine Society’s 2021 Annual Meeting, demonstrated a substantial drop in the use of bone-directed medications over the past decade, despite the rise in the number of osteoporotic-related fractures. It is unclear why this trend has occurred, but the main concern is that new diagnoses of osteoporosis are being overlooked.

This concern arose during a recent OrthoJOE podcast focused on distal radial fractures. OrthoEvidence Editor-in-Chief Dr. Mo Bhandari alluded to the confusion over who is responsible for bone-health intervention during treatment of a fragility fracture: the inpatient orthopaedic surgery team, the hospitalist, or the patient’s family physician or internist. “The thought is that someone is going to manage this,” Dr. Bhandari states. “Everyone is looking at everyone else, and it’s not happening.”

In fragility-fracture cases, JBJS Editor-in-Chief Dr. Marc Swiontkowski emphasized the importance of orthopaedic surgeons initiating investigations into their patients’ bone quality with evaluations of vitamin D, ionized calcium, and parathyroid and thyroid hormone levels. “We are failing miserably at this,” Dr. Swiontkowski laments, recalling seeing 3 elderly patients in a single day with a hip fracture that was preceded by a distal radial fracture a decade earlier–with no bone-health investigation ever performed at that time.

Initiatives like the American Orthopaedic Association’s (AOA’s) “Own The Bone” program try to raise awareness of our broader responsibility as orthopaedic surgeons when treating osteoporotic fractures such as those of the proximal femur, distal radius, and vertebrae. Drs. Bhandari and Swiontkowski strongly believe that the orthopaedic surgeon must claim ownership of their patients’ bone health, not necessarily by medically managing such cases, but by initiating a dialog with the patient’s primary care physician and/or rheumatologist/endocrinologist.

Click here to find out more about the AOA’s “Own The Bone” program.

James A. Blair, MD is the Director of Orthopaedic Trauma at the Medical College of Georgia at Augusta University and a member of the JBJS Social Media Advisory Board.

Targeted Muscle Reinnervation Helps Reduce—and Prevent—Pain in Amputees

Symptomatic neuromas have long been a problem for amputees, interfering with prosthetic comfort and causing residual pain that often requires treatment. During the last 15 to 20 years, surgeons have used targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) procedures to improve symptoms from neuromas. In TMR, surgeons transfer a mixed or sensory nerve to a “target” transected motor nerve to prevent disorganized axonal growth. RPNI is a less complicated procedure during which the free nerve end is implanted into a denervated free muscle graft, again to decrease disorganized sprouting of axons.

Advances in amputee care at US military centers, driven largely by recent overseas conflicts, have shown anecdotally that TMR and RPNI prevent neuroma formation when used prophylactically during initial amputation, and that they also relieve pain when used as secondary treatment for existing neuromas. In the April 22, 2021 issue of The Journal, Hoyt et al. reviewed records from Walter Reed National Military Medical Center to evaluate changes in pain scores, symptom resolution, and frequency of complications when TMR and/or RPNI were utilized.

The authors analyzed 87 nerve interface interventions in 80 lower extremity amputations that had at least 6 months of follow-up. Fifty-nine of the procedures (68%) were done to treat symptomatic neuromas at a median of 6.5 years after amputation, while 28 procedures (32%) were done for primary prophylaxis. Hoyt et al. found that the sciatic nerve was most likely to develop symptomatic neuromas after amputations at or above the knee, while the tibial and peroneal nerve distributions were most commonly symptomatic after amputations distal to the knee. TMR was utilized alone in 85% of the cases, and surgeons used RPNI most frequently to prevent pain in the sural and saphenous nerves.

Overall, symptom resolution after all procedures was 92% at the final follow-up. VAS pain scores improved from 4.3 to 1.7 points in the delayed-treatment group and did not vary by amputation level. The final mean pain score in the primary-prophylaxis group was 1.0 ±1.9. There were no significant differences in pain outcomes between the primary and delayed groups, but 6 patients in the delayed cohort required revision for residual limb or phantom limb pain. In patients with transtibial amputations, failure to address an asymptomatic tibial nerve during delayed TMR resulted in an increased risk of revision surgery.

Although retrospective in nature, this study shows some encouraging early data to support the primary and secondary use of TMR/RPNI in amputee care. More research is required to determine whether these results in wounded warriors can be replicated in a civilian amputee population.

Click here for a Commentary on this study by Ann R. Schwentker, MD.

Matthew R. Schmitz, MD
JBJS Deputy Editor for Social Media

Better TKA Outcomes When Depression Is Addressed

In the past decade, we’ve learned through a multitude of studies that patient factors can have a substantial impact on the outcomes of orthopaedic interventions. Medical comorbidities, body habitus, and level of fitness are just a few factors we have evaluated. We also now better understand the impact of socioeconomic status and education level on access to care and the results of that care. And importantly, contemporary research is giving us a more complete picture of the relationship between a patient’s mental status and functional outcomes.

Geng et al. provide further insight into this relationship in a recent JBJS report. In a randomized controlled trial conducted at their institution in the People’s Republic of China, the authors investigated whether psychological intervention for patients with depression improved outcomes of total knee arthroplasty (TKA). Among 600 patients prospectively screened, 53 were identified with depressive disorders; 49 remained in the final analysis (24 randomized to standard TKA care and 25 randomized to perioperative psychotherapeutic interventions administered by a mental health professional). Those in the intervention group not only had a significantly higher rate of satisfaction compared with the control group, but they also showed greater improvements in functional outcome scores, range of motion, and scores on depression scales.

As Pablo Castañeda, MD emphasizes in a related Commentary on this article, “Total knee replacement cannot be seen as an isolated intervention without considering the many other factors that contribute to outcomes.” I know that mental health concerns—especially depression—can be difficult to identify during all-too-brief orthopaedic consultations with patients. But they will reap important benefits if we learn to better recognize depression, engage patients in conversations related to mental health, and team with our mental health colleagues for referrals and support. The study by Geng et al. points to a model of care with potential for wider adoption. Considering our community of highly motivated orthopaedic surgeons who are dedicated to the holistic welfare of patients, I believe it is possible to raise our skills in this area close to the level of our ability to examine a knee radiograph.

Marc Swiontkowski, MD
JBJS Editor-in-Chief

Journal Club Resident Spotlight: Abdulaziz Ahmed

JBJS is pleased to highlight the orthopaedic residents who help implement the Robert Bucholz Resident Journal Club Grants at their institutions. The grant program promotes career-long skills in evaluating the orthopaedic literature. Click here for more information.

Name: Abdulaziz Ahmed, MD

Affiliation: Hamad Medical Corp., Doha, Qatar

What was the topic of the most “dynamic” journal club meeting you have had so far this year?

One distinctive journal club evaluated two Level-I studies that addressed common sports-medicine procedures. One article was a randomized clinical trial (RCT) that evaluated the effectiveness of acromioplasty when added to full-thickness rotator cuff tear repair (Abrams GD, et al. Arthroscopic Repair of Full-Thickness Rotator Cuff Tears with and Without Acromioplasty: Randomized Prospective Trial With 2-Year Follow-up. Am J Sports Med. 2014 Jun;42[6]:1296-303). The second article was a trial that compared hip arthroscopy versus nonoperative treatment for femoroacetabular impingement (Griffin DR, et al. Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome [UK FASHIoN]: a multicentre randomized controlled trial. Lancet. 2018 Jun 2;391[10136]:2225-2235). By completing systematic critical-appraisal forms, the residents were able to dissect and digest complex methodology and statistics. Both articles provided high-value learning points on evaluating the mechanics and limitations of randomized trials.

What are the top 3 characteristics of an engaging, enlightening journal club presentation?

First, audience preparedness is essential to an engaging journal club. Thus, articles should be distributed in advance for prereading. In our program, we circulate articles 4 weeks in advance. In addition, we highlight important educational objectives for each article. This allows residents to concentrate on crucial elements of selected articles, especially when analyzing several articles in one sitting. Second, selected articles have to be pertinent to the residents’ curriculum and clinical exposure. Our journal club articles are hand-picked jointly by senior residents and research-oriented faculty. The senior residents ensure the article’s relevance to residents, while experienced faculty provide oversight and refine article selection. Third, a systematic approach maximizes the beneficial value of the journal club. We provide participants with a systematic critical-appraisal checklist that not only enhances the residents’ critical appraisal, but also helps them adopt efficient lifelong reading tactics.

Aside from orthopaedic content, what have you been reading lately?

I have been reading the book Deep Work by Cal Newport. The book teaches valuable strategies for optimizing productivity and getting the most out of our cognitive abilities—a much-needed skill in our currently fast-paced, distracted world.

How has the COVID-19 pandemic affected your journal-club activities?

The COVID-19 pandemic has profoundly affected residency training around the globe. Although the pandemic limited our in-person journal club format, like many others, we have transitioned to virtual education. Currently, our journal club is conducted through online meetings. As much as we loved the in-person format, the online format made the journal club more accessible to faculty members. Moreover, the virtual setting motivated us to invite experts in the field. Recently, Dr. Bashir Zikria from Johns Hopkins moderated an exciting journal club on the long-term outcomes of matrix-induced autologous chondrocyte implantation.

How has free access to JBJS Clinical Classroom benefited you and your journal club?

JBJS Clinical Classroom has been a useful source for article selection in our journal club. It also provides an exciting opportunity to evaluate our knowledge by strengthening deficient areas and steering us away from mastered topics. The recharge feature provides a time-efficient way to reinforce knowledge.  Clinical Classroom presents questions that are based on the best available evidence, and cited references feature both classic and most recent articles.

 

Making History Together

JBJS announces its new, interactive website, Making History Together, which celebrates 130 years of history at JBJS and the collective history of the field of orthopaedic surgery. The focal point of the new site is a dynamic timeline highlighting key moments and people in orthopaedics from 1887 to the present.

“We designed this site to give you a glimpse into our shared, collective past and show you how JBJS and the field of orthopaedic surgery have evolved over the last century-plus,” says JBJS Editor-in-Chief Marc Swiontkowski, MD. “The site is both informative and entertaining, and we hope that it helps you to feel more closely connected to those who paved the way for current and future orthopaedic surgeons.”

Browse the Making History Together timeline here.

Watch the introductory video:

The Making History Together site also spotlights:

  • The people responsible for leading and producing JBJS, including our Editors-in-Chief, journal editors, reviewers, board of directors, and staff members
  • JBJS products, including our flagship Journal of Bone & Joint Surgery, additional print and digital publications, podcasts, videos, and educational events and offerings
  • Classic JBJS articles, including early and more recent practice-changing discoveries that were first described in our pages
  • How the JBJS organization has grown in size and scope over the years, from a small, scholarly, printed journal to a multimedia content hub that meets the needs of a global, interconnected community of orthopaedic surgeons

JBJS is proud of its role in helping to advance the field of orthopaedic surgery over the last 130 years and is honored to be part of an orthopaedic community with a shared dedication and commitment to improving the musculoskeletal care of patients worldwide.

Journal Club Resident Spotlight: Praharsha Mulpur

JBJS is pleased to highlight the orthopaedic residents who help implement the Robert Bucholz Resident Journal Club Grants at their institutions. The grant program promotes career-long skills in evaluating the orthopaedic literature. Click here for more information.

Name: Praharsha Mulpur, MD

Affiliation: Sunshine Bone and Joint Institute, Hyderabad, India

What was the topic of the most “dynamic” journal club meeting you have had so far this year?

Tuberculosis (TB) of the hip joint is still prevalent in India. We are often faced with situations of advanced destruction of the hip joint requiring total hip replacement (THR), but THR is usually delayed until the disease condition becomes quiescent. However, TB is known to persist subclinically and to reactivate after surgery. One of the journal club articles we discussed was a “practice changer” as far as THR in active TB was concerned: Kim et al. Total hip replacement for patients with active tuberculosis of the hip. Bone Joint J, 2013; 95-B:578-82.

What are the top 3 characteristics of an engaging, enlightening journal club presentation?

The most important characteristics include: (1) Clinical relevance: The article chosen should generate discussion on a topic that is clinically relevant and not one that has already been “settled” or “dismissed.” Not all “historical” articles are clinically relevant in the 21st century. (2) Participation: Participants should be well-versed with the topic prior to the meeting, which allows detailed discussion with different perspectives. (3) Brevity: Presentations of the article(s) being discussed should be clear and concise.

Aside from orthopaedic content, what have you been reading lately?

I am following several podcasts, both clinical and nonclinical. I am also reading articles from the Farnam Street blog by Shane Parrish, The New York Times, and a nonfiction book titled Nothing to Envy by Barbara Demick.

How has the COVID-19 pandemic affected your journal-club activities?

Unfortunately, our in-person journal clubs have been halted due to the ongoing risk of COVID transmission, and our institute and department have adopted a completely virtual academic program. This has advantages and disadvantages. On the positive side, we are able to involve senior faculty, both national and international, to participate in the journal club discussions. Apart from our monthly internal journal club, we have an ongoing academic relationship with the department of orthopaedics at the University of Miami for a monthly journal club. With this, our residents and fellows gain international perspectives on topics of clinical significance. On the downside, nothing beats an in-person meeting. Group dynamics and participation are always better in a room than on a Zoom screen.

How has free access to JBJS Clinical Classroom benefited you and your journal club?

JBJS Clinical Classroom is a valuable educational resource and is highly recommended for orthopaedic residents. The content is excellent and helped me cover a lot of topics without having to go back to a reference textbook. The progress meter is useful to assess personal progress. One of the best features is the JBJS Clinical Classroom Library. Every topic has links to the best or most-cited references, which makes studying easy.

Journal Club Resident Spotlight: Agustin Albani Forneris

JBJS is pleased to highlight the orthopaedic residents who help implement the Robert Bucholz Resident Journal Club Grants at their institutions. The grant program promotes career-long skills in evaluating the orthopaedic literature. Click here for more information.

Name: Agustin Albani Forneris, MD

Affiliation: Hospital Italiano de Buenos Aires, Argentina

What was the topic of the most “dynamic” journal club meeting you have had so far this year?

Many articles presented in our journal club ignited debate, not only about their findings but also their design and methodology. One standout was the article by Matsunaga et al. (Minimally Invasive Osteosynthesis with a Bridge Plate Versus a Functional Brace for Humeral Shaft Fractures: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Apr 5;99[7]:583-592), which is a prospective randomized study comparing minimally invasive osteosynthesis vs functional bracing for the treatment of humeral shaft fractures. It is quite unusual that a Level-I prospective study like this was designed in Latin America. Our debate focused primarily on identifying which patients in our population would benefit from one treatment or another, in order to apply specific indication criteria to our daily practice. In turn, several hypotheses were raised that stimulated ideas for future projects.

Based on your journal club experiences, what are the top 3 characteristics of an engaging, enlightening journal club presentation?

(1) The commitment of the participants. We encourage all of our 43 residents to not only read the article in advance but also to write a critical review as if they were reviewers of a journal.

(2) Selection of the article. We encourage residents to select controversial studies that trigger debate about results and methodology. It is often valuable to criticize an article whose methodology is controversial to analyze which aspects would make the same study more solid (i.e., selection bias, randomization, data collection, statistical analyses, etc.)

(3) Inviting an experienced faculty surgeon. This is always inspiring to all residents, helping us to write and review articles and transmitting to us their passion for research.

Aside from orthopaedic content, what have you been reading lately?

I am a technology fan, so I usually read specialized magazines on electronic devices and reviews about new gadgets on the market. During holidays, I love to read historical novels that transport me to another place and time. Reading about the achievements of people living at a time when life expectancy did not exceed 30 years amazes me.

How has the COVID-19 pandemic affected your journal-club activities?

Paradoxically, the pandemic empowered our journal-club activities. The substantial decrease in elective surgery to prioritize medical resources for Covid-patients, in addition to the proliferation of virtual applications, gave residents more accessibility to and availability for academic activities. The pandemic also enabled several staff surgeons to join our program, and that enriched the discussions.

How has your free access to JBJS Clinical Classroom benefited you and your journal club?

JBJS Clinical Classroom provides us the opportunity to link one of our most valuable learning tools with the journal club by synchronizing the topics from the resident program classes with the selected journals. JBJS Clinical Classroom also enables us to individualize each resident’s progress and to reinforce the areas that present the greatest difficulty.

Low Adherence to Open-Fracture Antibiotic Guidelines

The prompt administration of prophylactic antibiotics is considered a critical component of open-fracture management. In 2011, the Eastern Association for the Surgery of Trauma (EAST) recommended updates to traditional antibiotic administration, including gram-positive coverage for Gustilo Type-I and Type-II fractures, the addition of gram-negative coverage for Type-III, and additional penicillin for the presence of fecal or clostridial contamination. Concerns regarding the side effects of antibiotics, along with changing patterns in bacteria resistance, have led many treating physicians to consider alternative antibiotic choices.

In a recent JBJS article, Lin et al. report on the level of adherence to open-fracture antibiotic guidelines (both traditional and EAST recommendations), analyzing data collected as part of 2 large, ongoing, multicenter trials. They also evaluated the association of Gustilo type, wound contamination, and multifracture injuries with antibiotic choice and duration.

Included were 1,234 patients from 24 medical centers in the US and Canada, all of whom received antibiotics on the day of admission. While cefazolin monotherapy was the most commonly prescribed regimen (53.6%), 54 different combinations of prophylactic antibiotics were prescribed. Lin et al. found moderate adherence to traditional antibiotic treatment guidelines for Gustilo Types-I and II fractures and low adherence for Type-III, and less-than-optimal compliance with the EAST recommendations: 31% of Gustilo Type-I and Type-II fractures received gram-negative coverage, and 54.9% of Type-III fractures did not.

The authors offer many plausible reasons for low compliance, including increased incidence of methicillin-resistant S. aureus infections, concerns regarding the nephrotoxicity of aminoglycosides, and the more frequent use of intraoperative topical antibiotics.

The median duration of antibiotic use following wound closure in this study was 2 days. The authors note that the most widely recommended duration in the literature is 3 days after wound closure, which they add, contradicts the <24 hours recommended by the EAST guidelines (for Type-III fractures, discontinuation within 72 hours post-injury or 24 hours after soft-tissue coverage).

The study provides helpful insight into the sometimes contradictory and confusing guidelines for open-fracture antibiotic prophylaxis and the variations that exist in current practice patterns. It also begs the question: is it time for a stringent new look at the guidelines and more high-quality research into which practices help ensure the best patient outcomes and the most sensible antibiotic stewardship?

Matthew R. Schmitz, MD
JBJS Deputy Editor for Social Media

 

STAR Ankle Component Fracture: Awareness, Not Alarm

OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent “safety communication” from the FDA, the following commentary comes from Ariel Palanca, MD; Adam Bitterman, DO: and Christopher Gross, MD.

During the past decade, total ankle replacement (TAR) has been challenging the gold standard of ankle fusion for treatment of end-stage ankle arthritis. Improvements in TAR component design and refined surgical techniques have led to more predictable and reproducible outcomes.

On March 15, 2021, however, the US Food and Drug Administration (FDA) released a Safety Communication about the Scandinavian Total Ankle Replacement (STAR Ankle), a product line that DJO Surgical acquired from Stryker in November 2020. The FDA’s statement cites a “higher than expected” rate of fracture of the device’s mobile-bearing polyethylene component. The communication goes on to suggest that patients younger than 55 years old and those with an active lifestyle may have a higher risk of component fracture than older, more sedentary patients.

The STAR Ankle received premarket approval from the FDA in 2009, and the FDA is compiling data from 2 post-approval trials of the device. In August 2019, Stryker issued a safety notification regarding the higher-than-expected fracture risk for STAR polyethylene implanted before August 2014. The recent FDA safety notification states there may also be a high risk of fracture for STAR polyethylene components implanted after August 2014, although the agency’s notification acknowledges that “the long-term fracture rate is not known in devices manufactured after the 2014 packaging change.”

The “packaging change” mentioned above refers to the August 2014 changeover when STAR polyethylene started to be packaged in a foil pouch, which virtually eliminates oxidation of the polyethylene and should therefore reduce fracture rates. Additionally, many peer-reviewed journal articles have reported lower STAR-component fracture rates than those found in the post-approval trials at equal or longer follow-ups.

It’s also important to note that the 8-year follow-up FDA study that revealed a 13.8% cumulative polyethylene-fracture rate only included 87 of the 606 STAR patients in the clinical trial. Patients with complications are often more likely to follow up than those with no complications, creating a potential negative bias.

Still, to err on the side of caution, the FDA suggests that surgeons who treat and follow patients with a STAR implant closely monitor them–especially younger, more active patients–for potential component fractures until more post-approval data is analyzed to further clarify any risk.

Ariel Palanca, MD is an orthopaedic foot and ankle surgeon at Arch Health Medical Group in Escondido, California. Adam Bitterman, DO (@DrAdamBitterman) is a foot and ankle specialist, an assistant professor of orthopaedic surgery at Zucker School of Medicine at Hofstra/Northwell, and a member of the JBJS Social Media Advisory Board. Christopher Gross, MD is an orthopaedic surgeon specializing in foot and ankle disorders at the Medical University of South Carolina in Charleston and a member of the JBJS Social Media Advisory Board.