NCT00949494

Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)

Pilot Trial of Effects of Intra-articular Synvisc Therapy on Cartilage Determined by dGEMRIC in Patients With OA of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc when injected into knees of patients with knee OA by means of a specialized MRI technology (dGEMRIC).

Detailed description

Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative which is administered by injection into osteoarthritic joints for the treatment of osteoarthritis. Preclinical investigations have demonstrated that Hylan G-F 20 can favorably affect chondrocyte metabolism and recent clinical studies \[Ann Rheum Dis. 2004 May;63(5):478-82; Osteoarthritis Cartilage. 2005 Mar;13(3):216-24\] provide support for a disease-modifying effect of Hylan G-F 20 therapy. This study will utilize dGEMRIC imaging of patients with knee OA to assess the effects of Hylan G-F 20 therapy on cartilage in vivo over time. Delayed Gadolinium Enhanced MRI of the Cartilage (dGEMRIC) permits a quantitative assessment of GAG distribution within intact cartilage in vivo. Since dGEMRIC is noninvasive, the technique may be useful to non-invasively monitor the influence of various treatments on hyaline cartilage.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Synvisc	intra-articular, 3 weekly injections

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-06-01
• Completion: 2009-02-01
• First posted: 2009-07-30
• Last updated: 2019-09-10

Locations

2 sites across 1 country: United States