The Journal of Bone and Joint Surgery (American). 2009;91:1847-1853.
doi:10.2106/JBJS.H.01455
© 2009 The Journal of Bone and Joint Surgery, Inc.
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Complication Reporting in Orthopaedic Trials

A Systematic Review of Randomized Controlled Trials

S. Goldhahn, MD1, T. Sawaguchi, MD2, L. Audigé, PhD, DVM1, R. Mundi, BHSc3, B. Hanson, MD, MPH1, M. Bhandari, MD, MSc4 and J. Goldhahn, MD, MAS5

1 AO Clinical Investigation and Documentation, Stettbachstrasse 6, 8600 Dübendorf, Switzerland. E-mail address for S. Goldhahn: sabine.goldhahn{at}aofoundation.org
2 Department of Orthopaedic Surgery, Toyama Municipal Hospital, Imaizumihokubu 2-1, 939-8282 Toyama, Japan
3 Division of Orthopaedic Surgery, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4L8, Canada
4 Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Center, 1200 Main Street West, Room 2C3, Hamilton, ON L8N 3Z5, Canada
5 Musculoskeletal Research, Schulthess Clinic Zürich, Lengghalde 2, 8008 Zürich, Switzerland

Investigation performed at AO Clinical Investigation and Documentation, Dübendorf, Switzerland, and the Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Center, Hamilton, Ontario, Canada

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. 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. 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.

Background: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials.

Methods: Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories.

Results: One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications.

Conclusions: The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.


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Letters to the Editor:

Read all Letters to the Editor

Concern Regarding Complications Reporting in Orthopaedic Trials
Tao Cheng, MD, PhD, et al.
JBJS Online, 11 Sep 2009 [Full text]
Dr. Goldhahn and colleagues respond to Drs. Cheng and Zhang
Sabine Goldhahn, MD, et al.
JBJS Online, 11 Sep 2009 [Full text]