Institutional Review Board, Hospital for Special Surgery
November 20, 2009
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.
As this is a cadaver study, there is no subject recruitment.
Human cadaver thumb specimens under the age of 64 will be included in this study. The origin and insertion points of the ulnar collateral ligament and radial collateral ligament of the thumb MP joint will be identified and these attachment points will be used to anatomically reconstruct a new ligament. Range of motion and stability testing will be conducted on the native intact and reconstructed ligaments.
Krystle Hearns MA, Co-Director of Research, CHArm Center