Symposium cochairs Elena Losina, PhD; Jeffrey N. Katz, MD; and James G. Wright, MD, MPH, FRCSC, join young investigators Quanjun Cui, MD, MS; Wakenda Tyler, MD, MPH; and Hassan M.K. Ghomrawi, PhD, MPH, at the AAOS/ORS research symposium.

AAOS Now

Published 7/1/2009
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Mary Ann Porucznik

Clinical trials in orthopaedics: Not the oxymoron it seems

AAOS/ORS-sponsored symposium explores challenges, implications for clinical practice

“Randomized clinical trials are the accepted gold standard methodology for evaluating treatment effectiveness, but we don’t have as many as we need in orthopaedics,” said James G. Wright, MD, MPH, FRCSC, in his opening address at the 2009 AAOS/Orthopaedic Research Society (ORS) Clinical Trials in Orthopaedics Research Symposium.

“The culture of orthopaedics has been to accept—and even promote—divergent opinions, resulting in different treatments for the same condition,” he noted. This is largely due to a “predominance of uncontrolled clinical research.” Even the views held by senior clinical colleagues differ, so that patients may sometimes not receive the best treatment.

What’s the problem?
Several reasons can account for the lack of clinical trials in orthopaedics. They may involve rare events—such as seroconversion after an infected sharps injury—making it difficult to find enough participants. Trying to measure long-term outcomes—such as whether neonatal hip screening can help reduce the risk of arthritis developing—may take a lifetime. Patients may also be unwilling to participate in efforts to determine the effectiveness of one surgical technique compared to another.

Yet, noted Dr. Wright, a few case series have led to major advances in orthopaedics and, in some situations, to complete shifts in paradigm. He pointed to the development of total joint replacement, the use of internal fixation for fractures, spinal instrumentation techniques, and the shift from surgical to nonsurgical treatment of club foot based on the work of Ignacio V. Ponseti, MD. These advances, however, all occurred more than 30 years ago. In recent years, such dramatic advances have been infrequent.

“Contrast orthopaedics with other fields, notably pediatric cancer care, where randomized clinical trials have made significant advances. As many as 70 percent of children with malignancies are entered into clinical trials, and the survival rate—just 10 percent 30 years ago—is now approaching 85 percent. Orthopaedics hasn’t made these kinds of advances,” said Dr. Wright.

“An incredible opportunity”
Despite these challenges, “We can do clinical trials in orthopaedics,” insisted Dr. Wright. He pointed to a study published in the New England Journal of Medicine in 2002 on the use of arthroscopy for treating knee osteoarthritis. “That was placebo-controlled, challenged the prevailing treatment, and was met with a vehement response,” said Dr. Wright.

A second trial, conducted in 2008, addressed the same question with the same result.

More recently, a randomized, clinical trial compared the effectiveness of intralesional bone marrow versus steroid injections on simple bone cysts.

Dr. Wright pointed to the recent $1.1 billion allocated in the American Recovery and Reinvestment Act for comparative effectiveness research. “We have an incredible opportunity,” he said. “The time is right for orthopaedic clinical trials.”

In fact, the number of clinical trials in orthopaedics is increasing, as evidenced by the shift from case series to evidenced-based research in The Journal of Bone and Joint Surgery–American.

Impact on clinical practice
Randomized clinical trials are beginning to change clinical practice in a meaningful way. Already the evidence is being used by payors to determine what will be reimbursed.

What is needed, said Dr. Wright, is the strong and visible support of orthopaedic opinion leaders. “If orthopaedic thought leaders say we need more clinical trials, if they say it is not okay to have differences of opinion on treatment options, if they support the development of clinical practice guidelines, we will move inexorably to randomized clinical trials. We’re at a tipping point.”

Mary Ann Porucznik is managing editor of AAOS Now. She can be reached at porucznik@aaos.org

About the AAOS/ORS Research Symposia
Although the AAOS and the Orthopaedic Research Society (ORS) have been sponsoring scientific meetings together for more than 20 years, “Clinical Trials in Orthopaedics” is the first to focus exclusively on orthopaedic clinical trials. The symposium brought together experts from multiple disciplines to identify cultural barriers to conducting orthopaedic randomized clinical trials, to identify methodological issues, and to develop research priorities for future trials.

Participants included leading orthopaedic researchers, outstanding young investigators, and representatives from government and industry. Joining symposium cochairs Jeffrey N. Katz, MD; Elena Losina, PhD; and James G. Wright, MD, MPH, FRCSC, were, among others, Daniel J. Berry, MD, AAOS second vice president; Thomas A. Einhorn, MD; James D. Heckman, MD; Joan McGowan, PhD, of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); James Panagis, MD, MPH, director of the orthopaedics program within NIAMS; and Kristy L. Weber, MD, chair of the AAOS Council on Research, Quality Assessment, and Technology.

The Orthopaedic Research and Education Foundation and NIAMS joined the AAOS and ORS in sponsoring the symposium, which received educational support from DePuy, a Johnson & Johnson company.

A summary article on the results of the symposium will be published later this year in The Journal of Bone and Joint Surgery–American.