The Journal of Bone and Joint Surgery (American). 2008;90:62-67.
doi:10.2106/JBJS.G.01556
© 2008 The Journal of Bone and Joint Surgery, Inc.
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Outcome Assessment in Clinical Trials of Fracture-Healing

Saam Morshed, MD, MPH, Luis Corrales, MD, Harry Genant, MD and Theodore Miclau, III, MD

Corresponding author:
Theodore Miclau III, MD
Department of Orthopaedic Surgery, University of California—San Francisco, San Francisco General Hospital, 1001 Potrero Avenue, Room 3A-36, San Francisco, CA 94110.
E-mail address: miclaut{at}orthosurg.ucsf.edu

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 National Institutes of Health, The Doris Duke Clinical Research Fellowship, Wyeth, Lilly, Amgen, and Medtronics. In addition, 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, Lilly, Amgen, Medtronics, Hologic, and General Electric). 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.

Although there are numerous methods for defining fracture-healing in clinical studies, no consensus exists regarding the most valid and reliable manner for assessing union or for determining which outcomes are most important. This article summarizes and describes methods for the clinical assessment of fracture-healing and reports results from a systematic review of prevalent definitions currently used in published clinical studies. Conventional radiography and ad hoc clinical definitions continue to be the most commonly used means of assessing fracture-healing in clinical studies. Investigators must improve upon and apply more rigorous outcome assessment in clinical trials, emphasize patient-important outcomes, and report factors that may bias estimated effects.


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