OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent BMJ study, the following commentary comes from Matthew R. Schmitz, MD, FAOA.
Femoroacetabular impingement (FAI) syndrome continues to be a hot topic in the orthopaedic community. The first two decades of this century have seen huge increases in the number of hip arthroscopies performed in the US and UK,1,2 most of those to treat FAI. In the February 7, 2019 issue of BMJ, Palmer et al., reporting on behalf of the Femoroacetabular Impingement Trial (FAIT), published preliminary findings from a multicenter randomized controlled trial comparing arthroscopic hip surgery to activity modification and physiotherapy for symptomatic FAI.3
The trial randomized 222 patients with a clinical diagnosis of FAI into each cohort (110 in the physiotherapy group and 112 in the arthroscopy group). Follow-up assessments were performed by clinicians blinded to the treatment arm, and attempts were made to standardize both interventions. The participants will eventually be followed for 3 years, but this early report evaluated outcomes 8 months after randomization, with follow-up data available for >80% of patients in both groups.
Baseline characteristics with regard to demographics, radiographic findings, and clinical measurements were similar between the two groups. After adjusting for multiple potential confounders, the authors found that the mean Hip Outcomes Score Activities of Daily Living (HOS ADL) was 10 points higher in the arthroscopy group than in the physiotherapy group, exceeding the prespecified minimum clinically important difference (MCID) of 9 points. The MCID was reached in 51% of surgical patients compared to 32% in the therapy cohort. In addition, the patient acceptable symptomatic state (PASS)—defined as a HOS ADL ≥87 points—was achieved in 48% of surgical patients and only 19% of therapy patients. Relative to the physiotherapy group, the arthroscopic group also had better hip flexion and superior results in a variety of commonly used hip patient-reported outcomes scores.
The 8-month data from this study show that there is a real improvement in patient function and reported outcomes from arthroscopic management for FAI. It will be important, however, to follow these patients for the entire 3 years of the FAIT study to show whether these improvements persist. It should also be emphasized that only half of the patients treated with surgical management achieved MCID at the 8-month point. That finding supports what I tell patients in my young-adult hip-preservation clinics, which seems relevant as baseball season starts: There are rarely any home runs in arthroscopic hip surgery. There are mainly singles and doubles that we hope to stretch into doubles and triples. Still, it appears that even those base hits with arthroscopic surgery are better than the physiotherapy alternative—at least in the early innings of the game.
Matthew R. Schmitz, MD, FAOA is an orthopaedic surgeon specializing in adolescent sports and young adult hip preservation at the San Antonio Military Medical Center in San Antonio, TX. He is also a member of the JBJS Social Media Advisory Board.
- Maradit Kremers H, Schilz SR, Van Houten HK et al. Trends in Utilization and Outcomes of Hip Arthrocopy in the United States Between 2005 and 2013. J Arthroplasty 2017; 32:750-5.
- Palmer AJ, Malak TT, Broomfield J, et al. Past and projected temporal trends in arthroscopic hip surgery in England between 2002 and 2018. BMJ Open Sport Exerc Med 2016;2:e000082
- Palmer AJ, Gupta VA, Fernquest S, et al. Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicenter randomized controlled trial. BMJ 2019; 364:l185
Medical journal editors wield substantial power in deciding what gets published and potentially implemented in clinical practice. Theoretically, those decisions could be influenced by “commercial” relationships. To help ascertain the extent of such relationships, a recent retrospective observational study in the BMJ examined payments by US pharmaceutical and device manufacturers to 713 editors from 52 influential medical journals in 26 specialties, including orthopaedics.
Using data from the Open Payments database from 2014 and information gleaned from a survey of journal editors-in-chief, Liu et al. discovered the following:
- Among 713 editors, 50.6% received some “general payments” (i.e, money deposited directly into personal bank accounts) from pharmaceutical or medical device manufacturers in 2014.
- The median general payment to journal editors was $11, while the mean general payment was $28,136.
- The highest median payments were found among journal editors in the specialties of endocrinology ($7,207), cardiology ($2,664), gastroenterology ($696), rheumatology ($515), and urology ($480). The median payment among orthopaedics editors was $121.
- The two highest payments to individual editors were >$1 million, and those editors were in the specialties of cardiology and—you guessed it—orthopaedics.
Beyond the dollar-and-cents data, the authors discovered that only one-third of the 52 journal websites had readily accessible statements of conflict-of-interest (COI) polices. Among the journals with COI policies, 75% said they have formal recusal processes that exclude an editor from handling manuscripts where he/she has a conflict.
According to an accompanying appendix, among the 34 JBJS editors included in the analysis (i.e., the US-based editor-in-chief, deputy editors, and associate editors), six had received general payments >$50,000 in 2014. The JBJS COI statement asserts that if conflicts are disclosed that might affect an editor’s ability to adjudicate a manuscript fairly, “the paper will be reassigned to another editor.” It also states that “the Editor-in-Chief has no known conflicts of interests or competing interests and makes the final decision regarding acceptance or rejection of all manuscripts submitted.”
OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from E. Scott Paxton, MD, in response to a recent “Rapid Recommendation” in The BMJ.
An international panel convened by The BMJ recently issued a “Rapid Recommendation” that strongly recommends against using low-intensity pulsed ultrasound (LIPUS) in patients with fracture or osteotomy because the treatment doesn’t improve functional recovery or pain.1
The systematic review on which the recommendation was based reviewed 26 trials of nearly 1600 patients with fracture or osteotomy who were randomized to either LIPUS or sham/no device.2 The authors concluded with moderate to high levels of certainty that the treatment had little effect on the time patients could return to work, time to full weight-bearing activity, pain levels, future operations, or time to radiographic healing.
In 2009, Busse et al. performed a similar meta-analysis, concluding that “evidence for the effect of low intensity pulsed ultrasonography on healing of fractures is moderate to very low in quality and provides conflicting results.”3 This analysis only included 13 trials, however. Then, in 2016, Busse et al. published results from the TRUST study,4 a blinded, randomized controlled trial of 501 patients from 43 North American academic trauma centers who had a fresh tibial shaft fracture treated with intramedullary nailing. The authors based their sample size calculations on the minimal clinically important difference on the SF-36 PCS, as this was a co-primary outcome. The authors found no improvement in radiographic healing time or functional recovery with the use of LIPUS. However, the authors noted that only 1 nonunion occurred among 195 sham-treated patients, demonstrating that this group was at extremely low risk for nonunion at baseline.
Including the TRUST trial in the 2017 meta-analysis of LIPUS led Schandelmaier et al. to the aforementioned conclusions and informed the strong BMJ Rapid Recommendation against the use of LIPUS for patients with any bone fracture or osteotomy. However, this recommendation was based in large part on the TRUST trial, which was unable to directly assess the effectiveness of LIPUS on reducing nonunion rates because of the almost universal healing of the fractures studied.
The BMJ Rapid Recommendation states “there was high quality evidence showing a lack of benefit in accelerating healing for fresh fractures; thus it is unlikely that LIPUS would improve outcomes in patients with non-union.” However, the effect of LIPUS on preventing nonunions in fractures known to have high nonunion rates or on treating established nonunions will require further high-quality studies looking at those patients specifically.
Scott Paxton, MD is an assistant professor in the Department of Orthopaedic Surgery at the Warren Alpert Medical School at Brown University and a fellowship-trained shoulder and elbow surgeon at University Orthopedics in Providence, Rhode Island.
- Poolman RW, Agoritsas T, Siemieniuk RAC, et al. Low intensity pulsed ultrasound (LIPUS) for bone healing: a clinical practice guideline. BMJ. February 2017:j576-j576. doi:10.1136/bmj.j576.
- Schandelmaier S, Kaushal A, Lytvyn L, et al. Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials. BMJ. 2017;356:j656. doi:10.1136/bmj.j656.
- Busse JW, Kaur J, Mollon B, et al. Low intensity pulsed ultrasonography for fractures: systematic review of randomised controlled trials. BMJ. 2009;338:b351. doi:10.1136/bmj.b351.
- TRUST Investigators writing group, Busse JW, Bhandari M, et al. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016;355:i5351. doi:10.1136/bmj.i5351.
BMJ recently published two studies of interest to orthopaedists:
- After analyzing data from more than 200 cardiovascular, orthopaedic, and neurologic devices approved in both the US and European Union (EU), Hwang et al. found that those approved in the EU first were nearly three times as likely to trigger a safety alert or experience a recall than those first approved in the US. Finding further that trial results were published for fewer than half of approved devices considered “major innovations,” the authors call for “greater regulatory transparency” so physicians and patients can make better-informed decisions. Interestingly, Figure 2 in this study showed that the FDA approval time for orthopaedic devices was faster than ortho-device approval times in the EU. However, a JBJS study earlier this year found that devices approved via the FDA’s “quick” 510(k) process were 11.5 times more likely to be recalled than those cleared through the longer and more stringent FDA pathway.
- In the second BMJ article, a registry-based case-control study, Abrahamsen et al. found that the long-term use of the bisphosphonate alendronate does not increase the risk for atypical femoral fractures (either subtrochanteric or femoral shaft), while protecting against hip fractures. After applying some sophisticated statistical analyses, the authors estimated that 38 patients with ≥5 years of alendronate adherence would need to be treated for an additional 5 years to prevent one hip fracture, while 1449 similar patients would need to be treated to cause an atypical femoral fracture. Click here for more OrthoBuzz coverage of the relationship between bisphosphonates and atypical femoral fractures.