Status:
COMPLETED
Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee
Lead Sponsor:
Steadman Hawkins Research Foundation
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-80 years
Brief Summary
The goal of viscosupplementation is to replenish synovial fluid, which will improve patient symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has been shown to im...
Detailed Description
Upon initial visit, all study patients will complete an informed consent. After consent, patients will complete the baseline questionnaire packet, which includes a questionnaire with several validated...
Eligibility Criteria
Inclusion
- Men or women aged 18 to 80 years
- with a diagnosis of osteoarthritis of the knee. Diagnosis will be based on radiographic examination (Kellgren-Lawrence 2 or 3) or by previous arthroscopic diagnosis.
- Surgical treatment for osteoarthritis will be limited to arthroscopic surgeries that include removal of loose bodies, resection of unstable meniscus tears and loose or unstable chondral flaps, removal of osteophytes if they limit extension, and lysis of adhesions. These types of treatments may provide symptomatic relief by increasing joint volume in knees with osteoarthritis and relieving joint contact pressures.
Exclusion
- Patients with grade 4 Kellgren-Lawrence on radiographic examination will be excluded.
- Patients with a prior synovectomy on knee to be injected will be excluded.
- Patients will be excluded if they have rheumatoid disease or any other serious systemic disease, acute synovitis or excessive effusion, allergy to avian products/hyaluronan-based injection components/corticosteroid injection, pregnant, previous arthroscopic surgery within the last 6 months or had a joint infection within the previous 3 months.
- Patients who have undergone a prior synovectomy will not be included.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00312533
Start Date
April 1 2006
End Date
February 1 2008
Last Update
August 25 2008
Active Locations (1)
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1
Steadman Hawkins Clinic
Vail, Colorado, United States, 81657