Institutional Review Board, Hospital for Special Surgery
July 06, 2005
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.
Approximately 80 patients with osteoarthritis (OA), who have been indicated for knee arthroscopy surgery, will be screened for postoperative knee osteoarthritis treatment. Ideally, 60 patients will be enrolled in the study, however, a 20% dropout rate is being incorporated, resulting in approximately 50 patients completing the study.
After surgery, the study group will receive a series of Hyalgan® injections whereas the control group will not receive any injection. Both groups of patients will have their progress evaluated through radiographs at their 3 months postoperative visit and will be followed up to 6 months following there surgery.
Geoffrey Westrich, MD
Hospital for Special Surgery
535 East 70th Street, Rm. 324
New York, NY 10021