EAGLE European Post Market Study

Kensey Nash

Status: Completed

Conditions: Tear of Articular Cartilage of Knee, Current; Acute Knee Cartilage Injury

Treatments: Device: BioMatrix CRD

Study type: Observational

Funder types: Industry

Identifiers

NCT02309957

EAGLE EU Post Market Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-procedure KOOS Pain subscale score less than or equal to 70.
• ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures less than or equal to15mm in diameter.
• Cartilage lesion is amenable to treatment with a single BioMatrix CRD or an osteochondral autograft.

Exclusion criteria

• Previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended implantation site.
• Clinically significant (> 5 degrees) varus or valgus malalignment in either knee.
• Osteoarthritis in the injured knee.
• Inflammatory arthropathy
• Osteomyelitis or other active infection in either lower limb.
• Cortisone or hyaluronic acid knee injections in the past 3 months
• Body mass index greater than 35.

Trial design

33 participants in 1 patient group

BioMatrix CRD

Description:

All patients will receive BioMatrix CRD to repair an articular cartilage lesion or osteochondral defect.

Treatment:

Device: BioMatrix CRD