Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-16 @ 5:25 AM
Study NCT ID:
NCT02309957
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EAGLE European Post Market Study
Sponsor:
Kensey Nash Corporation
Organization:
Study Overview
Official Title:
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study
Status:
COMPLETED
Status Verified Date:
2019-08
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:
EAGLE
Brief Summary:
Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.
Detailed Description:
BioMatrix CRD is a CE marked device that is intended to repair focal articular cartilage lesions or osteochondral defects in the knee. BioMatrix CRD™ is a sterile, biphasic, bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. The device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the regeneration of cartilage and subchondral bone.
The purpose of this post-market study is to confirm the safety and performance of the BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10 hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.
The purpose of this post-market study is to confirm the safety and performance of the BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10 hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.
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?: