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The Orthopaedic Forum   |    
SymposiumHow to Participate in Orthopaedic Randomized Clinical Trials*
Stephen B. Trippel, MD1; Michael J. Bosse, MD2; David A. Heck, MD3; James G. Wright, MD4
1 Indiana University School of Medicine, 541 Clinical Drive, Suite 600, Indianapolis, IN 46202. E-mail address: strippel@iupui.edu
2 Department of Orthopaedic Surgery, Carolinas Medical Center, P.O. Box 32861, Charlotte, NC 28232
3 Baylor Health Care System, Institute for Health Care Research and Improvement, 8080 North Central Expressway, LB 81, Suite 500, Dallas, TX 75206
4 Department of Surgery, The Hospital for Sick Children, 555 University Avenue, Room 1254, Black Wing, Toronto, ON M5G 1X8, Canada
View Disclosures and Other Information
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 Veterans Administration, National Institutes of Health FOCUS Trial, Baylor Healthcare System, and R.B. Salter Chair in Surgical Research. One or more of the authors, or a member of his or her immediate family, received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from a commercial entity (Wyeth, Zimmer, and Pfizer). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
Presented at the 119th Annual Meeting of the American Orthopaedic Association, San Antonio, Texas, June 24, 2006.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2007 Aug 01;89(8):1856-1864. doi: 10.2106/JBJS.F.01596
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Extract

Rigorous orthopaedic clinical research should not be an oxymoron. The vitality of the orthopaedic specialty is critically dependent on well-designed and well-conducted clinical research targeted at the important questions facing orthopaedic surgeons and their patients. Randomized clinical trials are widely accepted as the most scientifically valid design for clinical research. Orthopaedic surgeons recognize this. Most would acknowledge that they search for high-level evidence-based research at scientific meetings and in journal publications. Most are sophisticated research evaluators who are aware that prospective, randomized, blinded data collection with controlled comparison provides the most valid evaluation of different surgical interventions. Orthopaedic surgeons can identify the biases and weaknesses of research reports and factor these into their interpretation of the results. In addition to using research, many orthopaedic surgeons participate in the conduct of clinical research. Generally, however, only a small percentage of orthopaedic surgeons participate in randomized clinical trials.
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    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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