Trials / Completed
CompletedNCT02309957
EAGLE European Post Market Study
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 33 (actual)
- Sponsor
- Kensey Nash Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioMatrix CRD |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2019-08-01
- Completion
- 2019-08-01
- First posted
- 2014-12-05
- Last updated
- 2019-08-21
Locations
6 sites across 4 countries: Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02309957. Inclusion in this directory is not an endorsement.