Institutional Review Board, Hospital for Special Surgery
February 04, 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.
We will examine the effects of platelet-rich-plasma (PRP) into regenerate bone following tibial osteotomy or unilateral deformity correction and we will compare it to a control group which will receive standard of care treatment. 62 patients will be included in this study; 31 of which will receive PRP injection and 31 which will receive standard of care treatment.
• All patients enrolled must be between 30 and 60 years of age, inclusive.
• Patients with leg length discrepancy or bone loss equal to or less than 5 cm.
• Patients requiring a single level tibial osteotomy (unilateral or bilateral) followed by external fixation and undergoing distraction osteogenesis with regenerate 5mm to 50mm.
• Patients greater than 60 or less than 30 years of age.
• Patients with leg length discrepancy or bone loss of greater than 5 cm.
• Significant metabolic bone disease (ex: Paget's, OI, Osteomalacia, etc)
• Tobacco smokers