Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00949494
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)
Sponsor:
Endeavor Health
Organization:
Study Overview
Official Title:
Pilot Trial of Effects of Intra-articular Synvisc Therapy on Cartilage Determined by dGEMRIC in Patients With OA of the Knee
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: