How to Participate in Orthopaedic Randomized Clinical Trials
Stephen B. Trippel, MD; Michael J. Bosse, MD; David A. Heck, MD; James G. Wright, MD

Rigorous orthopaedic clinical research should not be an oxymoron. The vitality of the orthopaedic specialty is critically dependent on well-designed and well-conducted clinical research targeted at the important questions facing orthopaedic surgeons and their patients. Randomized clinical trials are widely accepted as the most scientifically valid design for clinical research. Orthopaedic surgeons recognize this. Most would acknowledge that they search for high-level evidence-based research at scientific meetings and in journal publications. Most are sophisticated research evaluators who are aware that prospective, randomized, blinded data collection with controlled comparison provides the most valid evaluation of different surgical interventions. Orthopaedic surgeons can identify the biases and weaknesses of research reports and factor these into their interpretation of the results. In addition to using research, many orthopaedic surgeons participate in the conduct of clinical research. Generally, however, only a small percentage of orthopaedic surgeons participate in randomized clinical trials.

Although the number of randomized clinical trials published in The Journal Bone and Joint Surgery (American Volume) has increased over the last several years, they remain a relatively small percentage of the clinical research articles. Before 2000, a mere 10% of the studies published in The Journal were randomized trials1. In 2005, articles in The Journal that reported level-I evidence comprised 21% of the clinical studies. A large number of the articles in The Journal continue to be designed to provide only the lowest level of evidence. In 2005, 47% of the clinical studies in The Journal provided evidence that was rated level IV. Although the United States is the source of most of the articles published in The Journal, the proportion of level-I to level-IV studies in 2005 was higher for investigations performed abroad (44%) than for studies performed in the United States (38%). A recent review of the literature on …

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