RT Journal Article ID 7b8756995ac9fbf5 A1 Petrisor, Brad A. A1 Goldstein, Christina T1 Design Issues in a Non-Regulatory Trial JF Journal of Long-Term Effects of Medical Implants JO JLT YR 2009 FD 2009-10-01 VO 19 IS 3 SP 223 OP 233 K1 study design K1 randomized controlled trial K1 orthopedic implants K1 randomization K1 blinding K1 bias K1 study error AB 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. Unfortunately, RCTs involving different surgical techniques or implants present many challenges that may introduce bias and threaten the validity of study results. The purpose of this review is to outline these issues and present possible solutions to these challenges, with the ultimate goal of improving surgeons’ understanding of how to design and critically appraise RCTs involving orthopedic implants. PB Begell House LK https://www.dl.begellhouse.com/journals/1bef42082d7a0fdf,131c75161ccf6075,7b8756995ac9fbf5.html