Osteoarthritis
Conditions
Keywords
osteoarthritis, knee, hylan
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 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.
Interventions
DRUGintra-articular injection of Hylan G-F 20
Sponsors
Genzyme, a Sanofi Company
Cabrini Medical Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS \>39 mm on 100mm scale
Exclusion criteria
* surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cartilage volume as assessed by magnetic resonance imaging | — |
Countries
Australia
Contacts
Primary Contactstephen hall, MBBS, FRACP
Backup Contactmarie feletar, MBBS, FRACP
Outcome results
None listed