Institutional Review Board, Hospital for Special Surgery
January 19, 2016
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.
This observational study will compare patient-reported outcomes of surgery for lumbar degenerative spondylolisthesis. A total of 300 patients will be enrolled before surgery and receive a follow-up 2 years after surgery. The goals are to compare symptoms, function, fulfillment of expectations, and satisfaction with different types of surgery for this condition.
Patients undergoing surgery for lumbar degenerative spondylolisthesis are eligible if they are at least 18 years old and speak English.
Carol A. Mancuso, MD