Institutional Review Board, Hospital for Special Surgery
April 08, 2008
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.
It is estimated that 20 subjects will be identified with distal biceps tendon rupture repaired using the Endobutton technique. Patients will be contacted in attempt to arrange one additional post-operative follow up appointment. At this visit, additional data will include a VAS pain score, DASH questionnaire, ROM, and strength testing using isokinetic testing will be obtained. These outcomes will be measured at a minimum of 12 months post-operatively.
• Any adult patient who has undergone distal biceps repair using the EndoButton ™ technique performed by the PI or co-investigator with a minimum follow up of 12 months.
• Patients will not be excluded based on gender, ethnicity, or health status.
• Workers’ compensation patients will be identified and studied as a subgroup due to that group’s well-documented history of poor surgical outcomes.
• Patients who are under 18 years of age.
Scott Wolfe, MD