Randomized Controlled Trials in Orthopaedic Surgery

S. Raymond Golish, MD, PhD, and Paul A. Anderson, MD

Well-designed and conducted clinical research can support clinician utilization, regulatory approval, and payer coverage decisions for orthopaedic surgical procedures. Distinct study designs have advantages and drawbacks in each of these three areas.

Although experimental designs such as the randomized clinical trial (RCT) may be ideal in principle, well-conducted observational studies also have value, especially with respect to clinically established practice. Within RCTs, superiority studies (the experimental treatment is shown to be superior to the control treatment) are a gold standard. However, even well-conducted superiority trials can fail to maintain randomization and contain patients who are lost to follow-up or who cross over between randomized arms. This so-called partial compliance blurs the distinction between experimental and observational studies and complicates the interpretation of the resulting data. A separate article will address noninferiority trials, a recent trend in orthopaedic RCTs.

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