Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee

Cabrini Medical Centre

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: intra-articular injection of Hylan G-F 20

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00393393

05-11-07-05

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind