Institutional Review Board, Hospital for Special Surgery
May 11, 2011
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.
• Ages 45-55
• MRI – one or two tendon rotator cuff tears (isolated supraspinatus or supraspinatus and infraspinatus)
• Previous shoulder surgery
• Prior shoulder fracture or infection
• Subscapularis tears
• Massive rotator cuff tears (i.e. 3 or 4 tendon tears)
• Significant fatty infiltration of the rotator cuff muscles