The rapidly growing global burden of road-traffic accidents and fragility
fractures makes research on fracture repair a vital component of the efforts
needed to face this rising public health challenge. The focus on developing
new and innovative strategies to treat fractures is easily justifiable given
the potential human benefit from such discoveries. Randomized trials remain
the standard to which the evaluation of novel fracture-healing therapies must
continue to evolve. This article reviews randomized controlled trials in the
context of the hierarchy of evidence, special challenges to their conduct in
the setting of surgical research, and lessons learned from fracture-healing
trials published to date. Suggestions are made regarding the optimal
characteristics of fracture models and logistical consideration for ensuring
the success of future trials. The realization that surgical trials have unique
methodological and interpretative challenges has fueled a renewed vision of
the design and execution of large, definitive clinical trials with a
meaningful impact on the lives of patients.