Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT00393393
Status:
UNKNOWN
Last Update Posted:
2006-10-27
First Post:
2006-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee
Sponsor:
Cabrini Medical Centre
Organization:
Study Overview
Official Title:
A Single-Blind Prospective Parallel Control Group Pilot Study to Assess the Effect of Hylan G-F 20 (Synvisc) Supplementation on Cartilage Preservation in Osteoarthritis of the Knee
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
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:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: