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Hyalgan Treatment of Osteoarthritis in Post-Operative Knee Arthroplasty Patients

IRB Number: 22007
inactive

July 06, 2005

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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

Geoffrey Westrich, MD

Co-Investigators

Sarah Schaefer

Summary

Approximately 80 patients with osteoarthritis (OA), who have been indicated for knee arthroscopy surgery, will be screened for postoperative knee osteoarthritis treatment. Ideally, 60 patients will be enrolled in the study, however, a 20% dropout rate is being incorporated, resulting in approximately 50 patients completing the study.

After surgery, the study group will receive a series of Hyalgan® injections whereas the control group will not receive any injection. Both groups of patients will have their progress evaluated through radiographs at their 3 months postoperative visit and will be followed up to 6 months following there surgery.

Inclusion/Exclusion Criteria

Inclusion Criteria

  1. Knee arthroscopy: débridement
  2. Primary Osteoarthritis
    Clinical involvement of medial compartment (Grade 3 or 4), found prior to surgery through radiographs/MRI's or found during surgery:
    • meniscal pathology
    • chondromalacia patellae
  3. Age: 40 year or older
  4. Active disease (pain & disability) based on the signal joint: range of motion, visual analog scale (VAS) for pain, performance

Exclusion Criteria

  1. Pregnancy or breast feeding
  2. Failure to meet minimum criteria of the signal joint: range of motion, VAS pain, performance, etc.
  3. Patients with rheumatoid arthritis, a seronegative spondyloarthropathy or other underlying rheumatic condition that could be affecting the subject's knees.
  4. Patients with a current skin infection overlying the proposed injection site
  5. Patients with a history of allergy to avian products, hyaluronan or any study material
  6. Patients with concomitant diseases
  7. Patients undergoing anticoagulant therapy treatment

Contact Information

Principal Investigator
Geoffrey Westrich, MD
Hospital for Special Surgery
535 East 70th Street, Rm. 324
New York, NY 10021

Tel: 212.606.1510
Fax: 212.639.9266
Email: westrichg@hss.edu