Institutional Review Board, Hospital for Special Surgery
December 17, 2010
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.
This is a multi-site Research Study looking for 294 volunteers to examine the effects of a cooling and compression device upon the recovery of patients undergoing a Total Knee Replacement (TKA). HSS expects to enroll up to 75 patients. Every patient has an equal chance of being assigned either to the Game Ready Device which provides cooling and compression or the current gold standard treatment (ice and a compressive bandage) portion of the Study. There are 6 weeks of active participation for each volunteer including Physical Therapy (PT) evaluations before surgery, 24 hours prior to discharge from HSS, and at the two, three, four, five, and six week post-operative mark. Patients are asked to record pain medication usage and Game Ready device or ice and bandage usage for two weeks after surgery. Reimbursement up to $100 from an approved rehabilitation center and up to $50 from home for travel expenses related to Study visits will be provided. Patients who complete the Study requirements through the two-week PT evaluation will receive $25; those who complete the Study through the six-week PT evaluation will receive $100.
All patients 18 to 85 years old with a Body Mass Index of ≤ 40kg/m2 diagnosed with osteoarthritis undergoing a TKA with Drs. Su, Haas, Mayman, or Boettner are eligible. Exclusion criteria are as follows: patients who have had a TKA on the knee other than the one being replaced ≤ five months prior to surgery or are pregnant, a diagnosis of Rheumatoid Arthritis or active systemic disease (i.e. AIDS, HIV, hepatitis, etc.), severe edema or swelling in the leg on the same side of the TKA, history of thrombophlebitis or swelling of a vein caused by a blood clot in the lower legs, or those who have been previously enrolled in this Study.
Michelle Perna
Clinical Research Coordinator
pernam@hss.edu
212.606.1128