Institutional Review Board, Hospital for Special Surgery
August 27, 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.
Fifteen patients for thoraco-lumbar spinal fusions. All study data will be collected intraoperatively.
Patients 18 years or older presenting for multiple level (>5) posterior thoraco-lumbar spinal fusions are included.
Patients with severe pulmonary hypertension, right ventricular failure, aortic insufficiency and/or stenosis will be excluded.