Design Issues in a Non-Regulatory Trial

Randomized, controlled trials (RCTs) represent the highest level of evidence attainable. Although up to 60% of clinical questions cannot be answered by an RCT, it is still the ideal method of comparing orthopedic implants. The strength of the findings of RCTs is a result of the investigator’s ability to limit bias through careful attention to study design. Bias may be limited through randomization, allocation concealment, and blinding. …