The Journal of bone and joint surgery. American volume
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J Bone Joint Surg Am · Mar 2016
ReviewAnalysis of FDA-Approved Orthopaedic Devices and Their Recalls.
The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to existing devices. We hypothesized that orthopaedic devices are more likely to be cleared through the 510(k) process and thus are more susceptible to being recalled. ⋯ When orthopaedic surgeons are considering using a new device clinically in their patients, it is important for them to consider how the new device was approved by the FDA. If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety.
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J Bone Joint Surg Am · Dec 2015
ReviewIs There Truly "No Significant Difference"? Underpowered Randomized Controlled Trials in the Orthopaedic Literature.
Randomized controlled trials (RCTs) are considered the gold standard in evidence-based medicine. Underpowered RCTs that describe comparative outcomes without significance are of questionable benefit. The present study hypothesizes that a substantial proportion of RCTs in the orthopaedic literature that do not note significant differences between groups are inadequately powered. ⋯ If an RCT lacks adequate statistical power to identify a clinically meaningful absence of a difference between groups, there is an unacceptable risk of inappropriately failing to reject the null hypothesis. The present study found that a sizable proportion of RCTs in orthopaedic surgery in which the null hypothesis is rejected are inadequately powered. Researchers should consider this when designing clinical trials, and journal editors and reviewers should be wary of underpowered RCTs when considering manuscripts for publication.
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J Bone Joint Surg Am · Nov 2015
ReviewDatabase and Registry Research in Orthopaedic Surgery: Part 2: Clinical Registry Data.
The use of large-scale national databases for observational research in orthopaedic surgery has grown substantially in the last decade, and the data sets can be categorized as either administrative claims or clinical registries. Clinical registries contain secondary data on patients with a specific diagnosis or procedure. The data are typically used for patient outcome surveillance to improve patient safety and health-care quality. ⋯ Within the U. S., national joint registry adoption has lagged international joint registries. Given the changing health-care environment, it is likely that clinical registries will provide valuable information that has the potential to influence clinical practice improvement and health-care policy in the future.
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J Bone Joint Surg Am · Aug 2015
Review Comparative StudyIndustry Financial Relationships in Orthopaedic Surgery: Analysis of the Sunshine Act Open Payments Database and Comparison with Other Surgical Subspecialties.
Industry financial relationships for orthopaedic surgeons in the United States are now publicly reported in the Sunshine Act Open Payments database. We sought to present these data in a more easily understandable format and to describe how industry relationships in orthopaedic surgery compare with other surgical subspecialties. ⋯ One-half of U.S. orthopaedic surgeons have industry financial relationships reported in the Open Payments database. Orthopaedic surgeons are less likely than most surgical subspecialists to receive industry payments, and the majority of the overall value of orthopaedic financial relationships is driven by a small number of orthopaedic surgeons receiving royalties and licensing for reimbursable innovation within the field.