Institutional Review Board, Hospital for Special Surgery
April 07, 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.
The purpose of our study is to assess the effects of limb lengthening on the electrophysiology of nerves. The study will include 20 consecutive patients between the ages of 18 and 50. EMG/NCS will be conducted preoperatively and then monthly at each follow-up exam by Dr. Joseph Feinberg for up to 6 months if changes are noted during distraction. In case no changes are noted, the NCS/EMG evaluation will be stopped at 4 months
Patients undergoing proximal, middle, or distal tibial lengthening for stature lengthening or deformity correction who have normal preoperative nerve function. Patients will be assessed at an initial visit with Dr. Rozbruch or Dr. Fragomen.
Patients with prior nerve damage / neuropathy/ DM will be excluded.
Minors will be excluded.
Craig Fryman (Research Coordinator)