Institutional Review Board, Hospital for Special Surgery
December 10, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Answorth A. Allen, MD
Jo A. Hannafin, MD, PhD
Jeffrey Katz, MD, MS (Brigham and Women’s Hospital, Boston, MA)
Alejandro Leali, MD
Robert G. Marx MD, MSc, FRCSC
Andrew D. Pearle, MD
Jennifer Petrakis, DPT, MLT
Scott A. Rodeo, MD
Russell F. Warren, MD
Riley J. Williams III, MD
70 subjects will be recruited and randomly assigned to either physical therapy or surgery. The total duration of participation will be 2 years for each patient, which includes 2 visits and 3 mailings. Subjects will be screened for eligibility by an initial consultation with one of the study doctors. We are recruiting from the present to May of 2010.
Stuart Davidson, Clinical Research Coordinator