Clinical Trials in Orthopaedics Research. Part I. Cultural and Practical Barriers to Randomized Trials in Orthopaedics∗

Abstract

Randomized clinical trials are the most rigorous clinical research design. However, trials are expensive, time-consuming, and challenging to design and complete. In May 2009, the Clinical Trials in Orthopaedics Research Symposium, sponsored by the American Academy of Orthopaedic Surgeons (AAOS), the Orthopaedic Research and Education Foundation (OREF), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), brought together multiple disciplines to define a randomized clinical trials research agenda by focusing on important clinical questions in each subspecialty and to debate the major important methodological, cultural, and practical barriers to performing more randomized clinical trials in orthopaedics. We defined barriers as any challenge that makes a randomized clinical trial difficult to design or perform. We plan to report the deliberations of the Clinical Trials in Orthopaedics Research Symposium in three publications. The purpose of this first article is to present the cultural and practical barriers and to highlight the key infrastructure needed to support performing randomized trials in orthopaedics. We largely focused on randomized clinical trials but realized that methodologically sound prospective cohort studies also provide important information1. Our deliberations were clearly not exhaustive, and readers can refer to texts for basic information about randomized clinical trials not addressed during the symposium2. We have included the names of symposium speakers in parentheses after the title for each section. Randomized clinical trials have been infrequently performed in surgery3. We use the term culture in this article to reflect how orthopaedic surgeons resolve clinical questions, respond to clinical controversies, express their participation enthusiasm, and respond to the results of randomized clinical trials. Culture is one potential explanation for the paucity of trials in orthopaedics and may be a barrier to more trials. Each surgical procedure provides challenges that require ingenuity and often require deviations …