Institutional Review Board, Hospital for Special Surgery
March 22, 2012
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 study will establish a tissue registry using tissues that would otherwise be discarded at the time of surgery (synovial fluid and joint tissues, including cartilage, bone, synovium, and labrum). The purpose of the registry is to investigate the role of synovial inflammation in pre-operative symptoms and post-operative outcomes in patients undergoing surgery for femoro-acetabular impingement and/or acetabular labral pathology.
An estimated 100 subjects per year will be enrolled into this registry. The primary outcome will be the Hip Outcomes Score and secondary outcomes will include the Modified Harris Hip Score and the ihot33. These will be measured at 6 months and 2, 5 and 10 years after surgery as part of the existing Hip Preservation Registry (IRB #10036). Correlating these outcomes to the synovial pathology will allow us to investigate the role of synovial inflammation on post-surgical outcomes.
• Age 16-45
• Arthroscopic/surgical evidence of impingement and/or labral pathology without or with
synovial fluid effusion, inflamed synovium, and cartilage damage.
• History of tumor
• Reciprocal focal Grade 4 cartilage wear
• Infection in the index joint
• Advanced arthritis