ABSTRACT
PURPOSE: To our knowledge, no study has quantified the rate of discontinuation and nonpublication of randomized controlled trials (RCTs) regarding upper and lower extremity fractures. METHODS: We searched ClinicalTrials.gov on September 9th, 2020, for phase 3 and 4 RCTs pertaining to upper and lower extremity fractures. Trial completion status was determined using records available on ClinicalTrials.gov. Publication status was determined using records on ClinicalTrials.gov and by searching PubMed (MEDLINE), Embase, and Google Scholar. We queried corresponding authors on trial status if a peer-reviewed publication was not identified. RESULTS: Our final analysis included 142 RCTs, of which 57 (40.1%) were discontinued and 71 (50%) were unpublished. Thirty-six (of 57, 63.2%) discontinued trials failed to provide a reason for discontinuation, the most commonly identified reason for discontinuation was due to inadequate recruitment (13/21, 61.9%). Completed trials were more likely to reach publication (59/85; 69.4%; X2 = 32.92; P ≤ 0.001) than discontinued trials. Trials with more than 80 participants were less likely not to reach publication (AOR: 0.12; 95% CI 0.15-0.66). CONCLUSION: Our analysis of 142 upper and lower extremity fracture RCTs demonstrated one-half failed to reach publication and two-fifths were discontinued prior to trial completion. These findings indicate the need for increased guidance in developing, completing, and publishing RCTs in upper and lower extremity fractures. Discontinuation and nonpublication of orthopaedic RCTs hinder the public's access to collected data and negate the valued contribution from study participants. Discontinuation and non-publication of clinical trials may subject participants to potentially harmful interventions, limit the advancement of clinical research, and contribute to research waste. LEVEL OF EVIDENCE: III.
Subject(s)
Lower Extremity , Humans , Patient Selection , Data CollectionABSTRACT
Background: Systematic reviews on the use of platelet-rich plasma (PRP) in orthopaedic surgery are abundant in current published literature. However, a beautification of results (referred to as spin) has been noted in abstracts across various aspects of medicine. Purpose: To determine the prevalence of spin in systematic reviews of PRP-related orthopaedic surgery abstracts. Study Design: Cross-sectional study. Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Murad and Wang guidelines, we conducted a search in Medline, Embase, and the Cochrane Database for reviews on PRP-related orthopaedic surgery. The search included studies published from inception until June 30, 2021. Included were systematic reviews written in English that involved the use of PRP in the treatment of orthopaedic injuries in human participants. The abstracts of the included reviews were evaluated for the top 9 types of spin as described by Yavchitz et al in 2016. We determined the relationship between spin and study characteristics using odds ratios. Results: Of an initial 1560 studies, 176 were included. We found that 50 studies (28.4%) contained at least 1 form of spin. The 2 most common forms of spin found in our sample were type 5 ("Conclusion claims the beneficial effect of treatment despite high risk of bias"; n = 27 [15.3%]) and type 3 ("Selective reporting or overemphasis of efficacy in outcomes favoring beneficial effect of intervention"; n = 18 [10.2%]). No statistical significance was found between study characteristics and the presence of spin. Conclusion: Spin was present in 28% of the systematic reviews that covered PRP-related orthopaedic treatments. Spin was not associated with general study characteristics, including adherence to PRISMA guidelines or funding. Journals and authors should be aware of spin in articles and avoid its usage.
ABSTRACT
PURPOSE: To investigate whether pullout strength in the acellular dermal allograft matrix (ADM) used for superior capsule reconstruction depends on the distance from the edge of the graft. METHODS: ADM used for superior capsule reconstruction was obtained and cut into 30 squares. Two sutures were placed through the center of each graft by using a loaded Keith needle and forming a simple stitch. The grafts were divided into 3 groups of 10 grafts with a distance of 5 mm, 10 mm or 15 mm from the closest edge of the graft, respectively. The grafts were then preloaded to 5 N and pulled to failure at a rate of 12 mm/s on an MTS 858 MiniBionix servohydraulic mechanical test frame. The load to failure was recorded as well as the stiffness of each graft. RESULTS: The mean load to failure was 34.5 N (SD 7.89) for the 5 mm grafts, 31.7 N (SD 5.99) for the 10 mm grafts, and 66.2 N (SD 18.4) for the 15 mm grafts. There was a significant difference (< 0.0001) between the large grafts (15 mm) and the 2 smaller grafts (10 mm, 5 mm). There was no significant difference in stiffness between the groups of graft (P 0.40). CONCLUSION: Placing the suture at least 15 mm from the edge of the graft increases the graft's ultimate yield strength to suture pullout. CLINICAL RELEVANCE: The depths of the suture in ADM could improve pullout strength for constructs of superior capsular reconstructions.
ABSTRACT
CONTEXT: Injuries are common among high profile players in the National Basketball Association (NBA), and could provide an opportunity for physicians to provide accurate sports injury information and reliable rehabilitation data to the general public in the immediate aftermath. OBJECTIVES: To evaluate social media trends to investigate public interest in athletic injuries in the NBA and to evaluate the length of maintained interest in these injuries. METHODS: The Google Trends tool was used to analyze search data around two high profile players-Kevin Durant and Klay Thompson-who suffered injuries during the 2019 NBA Finals. The results were compared to the expected search forecast derived from an autoregressive integrated moving algorithm model. RESULTS: Both players were associated with a mean increase of 1,052.4% (standard deviation [SD], 703.96%) in relative search volumes for terms related to their injuries. This data showed a significant increase in search engine activity related to injuries associated with NBA players in the first 6.13 days (SD, 3.14 days) following the injuries, marking a substantial timeframe for public engagement. CONCLUSIONS: Search traffic information may be beneficial to the sports medicine community, as social media can provide a platform for patient education in a limited timeframe. By increasing patient awareness and knowledge regarding athletic injuries, social media can expand the pool of potential patients for physicians and surgeons.
