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Large Clinical Trials in Musculoskeletal Trauma: Are They Possible?Lessons Learned from the International Study of the Use of Rhbmp-2 in Open Tibial Fractures
Cristina Csimma, RPh, MHP1; Marc F. Swiontkowski, MD2
1 Wyeth Research, 87 Cambridge Park Drive, Office 3013, Cambridge, MA 02140. E-mail address: ccsimma@wyeth.com
2 Department of Orthopaedic Surgery, University of Minnesota, 2450 Riverside Avenue, Room 200, Minneapolis, MN 55454. E-mail address: swion001@umn.edu
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One author (C.C.) is an employee of Wyeth Research. In addition, one author (M.F.S.) received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (a consulting agreement for study design). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2005 Jan 01;87(1):218-222. doi: 10.2106/JBJS.D.01938
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As a result of medical complexity and urgent care needs, the trauma patient population has not been considered conducive to study with use of traditional clinical trial designs. Efforts to enhance the scientific rigor of clinical research in musculoskeletal trauma have highlighted several key outstanding needs that have not been met by most clinical studies to date. Large multicenter trials, international trials, large cohort outcome studies, and cost-benefit analyses are generally lacking in the orthopaedic trauma literature. There is an opportunity for clinical trials to produce broadly accepted treatment protocols.
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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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