Research

Effect of Limb Lengthening on Nerve Neurophysiology in Human Model

IRB Number: 29019
(inactive trial)

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.

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Principal Investigator

Robert Rozbruch, MD

Co-Investigators

Justin T. Fragomen, MD
Joseph Feinberg, MD
Raheel Shafi, MD
Craig J. Fryman, BS

Summary

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

Inclusion/Exclusion Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients with prior nerve damage / neuropathy/ DM will be excluded.
Minors will be excluded.

Contact Information

Craig Fryman (Research Coordinator)
646.797.8249
frymanc@hss.edu



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