Status:
UNKNOWN
Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee
Lead Sponsor:
Cabrini Medical Centre
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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
Detailed Description
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 seco...
Eligibility Criteria
Inclusion
- grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS \>39 mm on 100mm scale
Exclusion
- surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00393393
Start Date
January 1 2006
End Date
January 1 2006
Last Update
October 27 2006
Active Locations (1)
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1
Emeritus Research
Malvern, Victoria, Australia, 3144