Research

A Pilot Study to Evaluate the Safety and Efficacy of Amniotic Membrane Transplantation in Patients with Arthrofibrosis following Total Knee Arthroplasty

IRB Number: 14076

Institutional Review Board, Hospital for Special Surgery

August 18, 2014

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.

Principal Investigator

David J. Mayman, MD

Co-Investigators

Seth A. Jerabek, MD
Kaitlin M. Carroll

Summary

5 patients, and 6 month’s post operatively for follow-up.

Inclusion/Exclusion Criteria

  • Inclusion Criteria: (1) Patients with mature arthrofibrosis who are a minimum of 1 year post TKA and (2) Documented flexion less than 90 degrees.
  • Exclusion Criteria: Patients that are wheelchair bound.

Contact Information

David J. Mayman, MD
maymand@hss.edu
212.774.2024



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