HSS Home / Research / Clinical Trials / IRB Number 25107

July 17, 2006

Prospective Assessment of the Effects of Hyalgan on Cartilage in Patients with Primary Osteoarthritis

IRB Number: 25107

Institutional Review Board
Hospital for Special Surgery


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

Lisa Mandl, MD, MPH

Co-Investigators

Hollis G. Potter, MD
Scott A. Rodeo, MD
Helene Pavlov, MD, FACR
Jennifer L. Solomon, MD
Li Foong Foo, MBChB
Elizabeth Gluck
Jason Grossman
Carla R. Scanzello, MD
Mary K. Crow, MD
Robert G. Marx, MD, MSc, FRCSC
Stephen Lyman, MD
Rolando Duculan
Liang Ying

Summary

A total of 40 subjects with knee osteoarthritis will participate in this study at HSS.  20 patients will receive an injection of Hyalgan (HA), a medicine approved by the FDA for use in the knee.  The other 20 patients will receive an alternative standard form of care in treating knee arthritis.  The HA group will involve a total of 12 study visits, The other group will have a total of 4 study visits.  All patients will also be mailed two questionnaires to fill out, at 3 months and 9 months.  Most visits are expected to last 30 minutes.  Three of the visits will last about 2 hours.

Inclusion/Exclusion Criteria

Inclusion Criteria:

  • age 45-90
  • seeking medical care for painful knee osteoarthritis

Exclusion Criteria:

  • previous HA injection in the knee
  • Allergies to HA or chicken products
  • A recent injury to the knee
  • Unwilling to discontinue or avoid glucosamine chondroitin sulfate for the 12 month study period
  • People taking blood thinners or who have bleeding problems
  • Anticipated lower extremity surgery during the next 12 months

Contact Information

Clinical Research Coordinator – 212.774.2754





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