THURSDAY, Aug. 6 (HealthDay News) -- Orthopedic clinical trials show a lack of consistency in complication reporting, suggesting the need to develop a standardized protocol for complication assessment and reporting, according to a study published in the Aug. 1 issue of the Journal of Bone & Joint Surgery.

Sabine Goldhahn, M.D., of AO Clinical Investigation and Documentation in Dubendorf, Switzerland, and colleagues screened five orthopedic journals for trials published between January 2006 and July 2007.

The authors conducted a systematic review of 112 randomized controlled trials, two-thirds of which included complications as trial outcomes. However, they found that only eight trials included clear definitions of anticipated complications, only 17 percent of trials identified the researcher or group charged with complication assessment, and none of the trials included a data safety review board to assess and classify complications.

"On the basis of this review, we suggest that the following be considered by those conducting future orthopedic trials. 1. A randomized controlled trial should be performed if possible. 2. Complications should be included as an outcome in any clinical investigation plan. 3. Anticipated complications should be defined prior to the start of the study. 4. There should be a blinded assessment of the outcomes. 5. Complications should be monitored by an independent and competent data review board. 6. There should be a safety analysis of complications within a standard minimum observation period," the authors conclude.

Abstract
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