Multicenter Clinical Trials in Orthopaedics

Abstract

Orthopaedic surgeons want what is best for their patients. Determining best practice, however, is not always straightforward. Clinicians use many sources of information to determine treatment options for their patients. Surgeons rely in large part on their training. As surgeons progress through their careers, practice learned through training is influenced by their own experience, the advice of colleagues, and their personal learning, including continuing medical education and the use of texts or the surgical literature. One of the more powerful forces in shaping best practice is, and should be, the surgical literature. The literature, however, is often contradictory. Contradictory literature leads to conflicting treatment recommendations for many conditions, and, in some situations, to a complacency among surgeons that anything goes (as surgeons can find some support for just about anything in the literature). Varying treatment recommendations in the literature and subsequent variation in practice may be acceptable if different treatments address different clinical situations, if different treatments have similar outcomes, or if different treatments address the variation in patient preferences. Barring these circumstances, if different treatments have meaningful differences in outcome, then practice variation may adversely affect patient outcomes. Why do the recommendations for treatment reported in the literature vary for many conditions? At least some of the variation in the surgical literature reflects the variation in study quality. Surgeons intuitively recognize that a more rigorous research design provides more convincing and dependable results. Study design is the basis for levels of evidence. Although critical appraisal is required to determine the merit of an individual study, according to the Levels of Evidence in The Journal of Bone and Joint Surgery 1 , randomized trials (Level I) are considered the highest quality research. Although the case series (Level IV), the predominant form of orthopaedic research, are considered a less rigorous research …