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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.2015013786
pages 215-223

Ethical and Methodological Issues Surrounding the Use of Appropriate Comparators in Orthopaedic Surgery Randomized Controlled Trials

Alisha Hak
Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada
Nathan Evaniew
Division of Orthopaedic Surgery, Center for Evidence-Based Orthopaedics, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON L8L 8E7, Canada
Mohit Bhandari
CLARITY Research Group, McMaster University, Department of Orthopedic Surgery Musculoskeletal Research Unit, Canada and Division of Orthopaedic Surgery and Department of Clinical Epidemiology & Biostatistics, Hamilton General Hospital, Canada

ABSTRACT

Although randomized controlled trials (RCTs) have the ability to provide researchers with more concrete evidence than that of their nonrandomized counterparts, conducting an RCT brings with it many ethical and methodological considerations. It is understood that in order to progress knowledge, and create new knowledge to benefit future patients, research must include human subjects; however, the desire to further knowledge must be placed second to the safety and respect for trial participants. An important ethical and methodological step in the design of any trial once the intervention is established is the selection of the comparator treatment. This is especially a topic of interest in orthopaedic surgery trials, in which a placebo comparator is not always possible and, arguably, sometimes never ethical. We review the use of different comparators in the treatment of orthopaedic surgery injuries and conditions, taking into consideration methodological and ethical issues. Comparators assessed are established treatments, standard-of-care treatments, conservative treatments, placebos, and sham surgeries.