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Journal of Long-Term Effects of Medical Implants
SJR: 0.332 SNIP: 0.491 CiteScore™: 0.89

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v19.i3.80
pages 223-233

Design Issues in a Non-Regulatory Trial

Christina Goldstein
Department of Surgery, Division of Orthopaedics, McMaster University, Hamilton Health Sciences, Canada
Brad A. Petrisor
Division of Orthopaedic Surgery, Department of Surgery, Centre for Evidence-Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada


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.