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Sponsors and Collaborators: |
Cabrini Medical Centre Genzyme |
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Information provided by: | Cabrini Medical Centre |
ClinicalTrials.gov Identifier: | NCT00393393 |
That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a 12 month period in subjects with moderate to marked osteoarthritis of the knee
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis |
Drug: intra-articular injection of Hylan G-F 20 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Single-Blind Prospective Parallel Control Group Pilot Study to Assess the Effect of Hylan G-F 20 (Synvisc) Supplementation on Cartilage Preservation in Osteoarthritis of the Knee |
Estimated Enrollment: | 80 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2006 |
Two courses of Hylan G-F 20 ( Synvisc) administered by intra-articular injection at 6 monthly intervals. MRI examinations of the knee for estimation of cartilage volume prior to treatment, before second course and at 12 months in 40 subjects with Grade 2/3 osteoarthritis of knee . A further 40 subjects with similar degree of osteoarthritis of knee who do not receive Hylan G-F therapy will be assessed by MRI in identical manner.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: stephen hall, MBBS, FRACP | 613 9509 6166 | drshall@ozemail.com.au |
Contact: marie feletar, MBBS, FRACP | 613 9509 6166 | mfeletar@westnet.com.au |
Australia, Victoria | |
Emeritus Research | Recruiting |
Malvern, Victoria, Australia, 3144 | |
Principal Investigator: stephen hall, MBBS, FRACP |
Principal Investigator: | stephen hall, MBBS, FRACP | Cabrini Medical Centre |
Study ID Numbers: | 05-11-07-05 |
Study First Received: | October 26, 2006 |
Last Updated: | October 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00393393 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
osteoarthritis knee hylan |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |