Proper design of clinical trials for the assessment of bone graft substitutes.

Abstract

To assess the effectiveness and safety of engineered bone graft substitutes proper, clinical trials will need to be performed. Although the randomized placebo controlled prospective clinical trial is the gold standard, clinical trials of this design are difficult to perform in the surgical setting. At this writing, several clinical trials evaluating bone graft materials have been performed, and much was learned toward improving the design of future studies. This article reviews alternatives to the placebo controlled randomized clinical trials in the surgical setting. The importance of long term surveillance is emphasized.