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The Orthopaedic Forum   |    
The American Orthopaedic Association Clinical Trials Curriculum
Ivan R. Diamond, MD1; Camille Murray, MHS2; Michael J. Bosse, MD3; James D. Heckman, MD4; Sohail K. Mirza, MD5; Terrance D. Peabody, MD6; Khaled J. Saleh, MD7; Marc F. Swiontkowski, MD8; James G. Wright, MD1
1 The Hospital for Sick Children, 555 University Avenue, Toronto, ON M5G 1X8, Canada. E-mail address for J.G. Wright: james.wright@sickkids.ca
2 American Orthopaedic Association, 6300 North River Road, Suite 505, Rosemont, IL 60018
3 Department of Orthopaedic Surgery, Carolinas Medical Center, P.O. Box 32861, 1320 Scott Avenue, Charlotte, NC 28232
4 The Journal of Bone and Joint Surgery, 20 Pickering Street, Needham, MA 02492-3157
5 Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756
6 University of Chicago Hospitals and Clinics, MC 3079, 5841 South Maryland Avenue, Chicago, IL 60637
7 University of Virginia, P.O. Box 800159, Charlottesville, VA 22908-0159
8 Department of Orthopaedic Surgery, University of Minnesota, 2450 Riverside Avenue South, Minneapolis, MN 55454
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Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from The Journal of Bone and Joint Surgery and the Orthopaedic Research and Education Foundation. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2009 Apr 01;91(4):1007-1011. doi: 10.2106/JBJS.H.01864
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In clinical care, high-quality, randomized controlled trials are generally acknowledged to provide the best evidence in evaluating treatment efficacy1. However, the proportion of orthopaedic publications that are clinical trials is relatively low. Although the frequency is increasing2, many surgical trials are of low quality3,4. The reasons for the low number and poor quality of surgical trials are multifactorial5-7. The design and conduct of surgical randomized trials pose unique challenges, including small numbers of patients, the heterogeneity of surgical patients, acceptability of randomization for surgical procedures, difficulty in standardizing surgical procedures, and issues of surgical proficiency such as the learning curve. Although blinded trials afford the best opportunity for unbiased assessment of outcomes, such trials are not always feasible in the surgical setting where the comparator group may be a less invasive procedure or a nonoperative approach. Despite these challenges, many questions in orthopaedics are amenable to clinical trials. In order to increase the number of trials, orthopaedic surgeons need an appreciation of a well-designed clinical trial. The objective of this article is to describe the rationale, objectives, design, and preliminary evaluation of a curriculum developed by the American Orthopaedic Association (AOA) to facilitate the conduct of clinical trials in orthopaedics.
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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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