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HSS Research Institute

Lower Extremity Realignment Therapy for the Treatment of Medial Knee Osteoarthritis- A Pilot Study

IRB Number: 28008

Institutional Review Board, Hospital for Special Surgery

August 02, 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.

Principal Investigator

Howard J. Hillstrom, PhD


Sherry Backus, PT, DPT, MA
Eric Bogner, MD
Frank A. Cordasco, MD, MS
Jocelyn Hafer, MA
Glenn Garrison, CPO
David Hunter, MD, PhD
Yatin Kirane, D.Orth, PhD
Andrew Kraszewski, MS
Mark Lenhoff, BS
Stephen Lyman, PhD
Lisa A. Mandl, MD, MPH
Helene Pavlov, MD, FACR
Hollis G. Potter, MD
Scott A. Rodeo, MD
Peter Torzilli, PhD
Thomas L Wickiewicz, MD
Riley J. Williams, MD


The unloading braces are designed to “unload” a knee compartment in knee osteoarthritis (OA).  The goal of this clinical trial is to evaluate the effects of unloading brace treatment on knee pain, structure, and function in individuals with mild to moderate medial knee OA and a varus deformity. A total of twenty individuals with medial compartment knee OA will be recruited in this ongoing study, and the recruitment is currently open.  Following screening and selection, a custom unloading brace is prescribed.  The brace is worn by the individual for a minimum of 6 hours a day and 5 days a week for one year.  Special X-ray views are done at the beginning and upon completion of the study.  Knee pain and function are assessed by means of questionnaires.  Walking movement is analyzed using a 12-camera 3D motion capture system and other state-of-art equipment.  The knee joint fluid is collected three times during the course of the study for measurement of OA biomarkers (e.g. cartilage degradation products and enzymes). The changes in the radiographic measurements, knee pain, function, motion patterns and OA biomarkers in the joint fluid are analyzed before, during and after one year of bracing treatment.

Inclusion/Exclusion Criteria

Inclusion Criteria:

• Men and women between the ages of 40 and 80 years
• Mild to moderate knee OA
• Ability to walk independently without an assistive device

Exclusion Criteria:

• Pregnant or nursing women
• Advanced OA in other knee
• History of replacement surgery of any lower limb joint
• Neuro-musculo-skeletal condition that interferes with walking gait (e.g. rheumatoid arthritis, psoriasis, gout, joint infection, venous or lymphatic leg stasis, peripheral vascular disease, etc.)
• Significantly compromised cardiovascular condition
• Currently taking anticoagulants and narcotic analgesics
7. Contact Information for the study:

Contact Information

Howard J. Hillstrom, Ph.D.