A study published in the May 3 issue of The Journal of Bone & Joint Surgery finds wide variation in reporting and strength of clinical research methodology accepted by the U.S. Food and Drug Administration (FDA) to approve high-risk orthopaedic devices. 

The researchers audited study design and methodology of 49 studies used by FDA to evaluate the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. They found that 46 were prospective, 37 were randomized, and 47 were controlled in some form. Of 35 studies that reported it, 13 were double-blind and 8 were single-blind. Of the 37 randomized trials, outcome assessors were clearly blinded in six (16 percent), while 15 (41 percent) were deemed impossible to blind, as implants could be readily discerned on imaging. When the Checklist to Evaluate a Report of a Nonpharmacological Trial was applied to the 37 randomized trials, more than 70 percent of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. Learn more...

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