Institutional Review Board, Hospital for Special Surgery
October 16, 2007
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.
20 healthy subjects without thumb osteoarthritis will be recruited.
Subjects will be screened for eligibility through a questionnaire and free hand x-ray and once enrolled will perform a strength and dexterity test and fill out several questionnaires twice, 4 weeks apart.
• Over 45 years old.
• No pain from thumb OA.
• Radiographic evidence of > 2 Kellgren and Lawrence joint narrowing or osteophytes (on a scale of 0-4), or any sclerosis at the CMC joint.
Clinical Research Coordinator