Are large fracture trials possible?

Reliable clinical orthopaedic trauma research is important and necessary to guide orthopaedic surgeons and their patients to best practices and expected outcomes. Currently, most fracture care is guided by suboptimal clinical research. To address this need, large fracture trials are necessary to deliver Level I evidence and direct the orthopaedic trauma surgeon in the best treatments. Although trials of this nature have been rare, they have been completed successfully. Although each fracture trial comes with its own set of obstacles, the trial can be successful with proper expertise, study planning, and study design. The purpose of this article is to present the rationale, methodology, and implementation strategies to successfully complete a large fracture trial. © 2010 by Lippincott Williams & Wilkins.