Institutional Review Board, Hospital for Special Surgery
July 08, 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.
Daniel Maalouf, MD
Karina Gritsenko, MD
Barbara Wukovits, RN
Heejung Bang, PhD
Hanne Storm, MD
James Bae, MSc
Janet Cahill, PT, MS
We are recruiting a total of 250 patients. This study is validating a device that could possibly objectify pain scores. This machine could lead to further groundbreaking research that could change the practice of pain management. This could be applied to all patients post-operatively. Follow up will be performed on POD 1 and 2.
Dysautonomia Sympathetic dysfunction such as:
- Raynaud disease, Buerger disease
- Disorders of sweating such as: Acquired idiopathic generalized anhidrosis