Institutional Review Board, Hospital for Special Surgery
March 18, 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.
The goal of this clinical trial is to evaluate the effectiveness of using MPFL reconstruction surgery to treat recurrent patellofemoral (PF) instability in patients without patella alta. Though many surgeons use the tibial-tubercle-to-trochlear groove (TT-TG) and patella alta as guides for treatment, abnormal measurements have not been proven in the literature to predispose patients to failure of soft tissue procedures. Bony procedures often used to treat recurrent PF instability, such as tibial tubercle osteotomy, carry significantly more morbidity than soft tissue procedures, so patients would benefit from avoiding these procedures if possible.
Patients who have undergone a prior attempt at surgical stabilization of their unstable patellofemoral joint, and patients with significant cartilage lesions who are indicated for an unloading procedure such as tibial tubercle osteotomy, will be excluded
Beth E. Shubin Stein, MD