Institutional Review Board, Hospital for Special Surgery
July 21, 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.
As subject population will be determined via retrospective chart review, we are not actively recruiting subjects.
Patient charts will be identified through retrospective review of the co-investigators’ files. The review will include all patients diagnosed with ultra-small proximal pole scaphoid fractures who underwent fixation using a micro screw for small bone fragments, such as the Acutrak 2 Micro.
Post surgical scaphoid union and range of motion will be evaluated.
N/A – we are not actively recruiting subjects