Institutional Review Board, Hospital for Special Surgery
July 07, 2008
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.
During knee surgery your surgeon routinely uses a device called a tourniquet that allows us to temporarily cut of blood supply to the site of surgery. This helps to reduce blood loss and improves operating conditions. When allowing blood back into your leg at the end of the procedure, debris (bone, fat, tissue breakdown products and cement from the surgery) gets washed out and gains access to the rest of your body. In the vast majority of cases this event bares no major clinical consequences, but can result in signs of inflammation of various body systems. Patients with evidence of impaired organ system function such as pre-existing lung and heart disease may be more vulnerable. Previous studies suggest, that cutting off the blood supply for a short period of time just before a prolonged episode, could lead to a decrease in the extent of tissue breakdown products in this extremity and may thus be associated with a decrease in the inflammation of other organ systems.
We propose to study this theory in knee surgery patients by looking at levels of markers of inflammation present in the blood before and after tourniquet release (5 min, 6h, 12h, 24h). We plan to enroll a total of 34 patients total in this study.
All patients non-pregnant patients between the ages of 18 and 85 undergoing knee surgery except:
Patients who are on immune-suppressants (including preoperative steroids).
Patients with contraindications (severe peripheral vascular disease, presence of femoral-popliteal bypass grafts, etc.) or no plan for tourniquet use as determined by the clinical care team.
Stavros G. Memtsoudis, MD