Institutional Review Board, Hospital for Special Surgery
February 04, 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.
Demetris Delos, MD
Samuel A. Taylor, MD
Ashley M. Newman, BS
Kelli Gallagher, PA
Kevin Strang, BA
Nicole Sliva, BA
150-200 patients who fit the inclusion and exclusion criteria (see below) will be enrolled in this retrospective study with clinical follow up. All are patients of the principle investigator, Dr. Stephen O’Brien. A detailed discussion of the study’s goals and asked participation will be had with the patient. After an informed is signed, the patient will be asked to fill out a series of approved questionnaires and undergo a brief physical examination. Data will be analyzed and maintained confidential as outlined above.
• Age 15-65 years
• No previous biceps surgery
• Diagnosis of biceps tendonitis or instability
• Failed conservative treatment (including anti-inflammatory medications, physical therapy, rest)
• Underwent arthroscopic assisted or all arthroscopic transfer of the LHBT to the conjoint tendon after failed course of conservative treatment
• Previous LHBT surgery
Dr. Stephen J. O’Brien, MD, MBA