May 11, 2011
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Inclusion Criteria:
• Ages 45-55
• MRI – one or two tendon rotator cuff tears (isolated supraspinatus or supraspinatus and infraspinatus)
Exclusion Criteria:
• 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