Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-06 @ 6:44 PM
Study NCT ID:
NCT00984594
Status:
TERMINATED
Last Update Posted:
2014-06-04
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Sponsor:
RTI Surgical
Organization:
Study Overview
Official Title:
Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrolment \& potential regulatory changes for allograft in cartilage repair
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).
Detailed Description:
The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (\<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.
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?: