EAGLE European Post Market Study

Kensey Nash Corporation33 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Knee Cartilage Injury Tear of Articular Cartilage of Knee, Current

Interventions

BioMatrix CRDDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

University of Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Technische Universität München

München, Germany

Klinikum der Universität Regensburg

Regensburg, Germany

Istituto Ortopedico Rizzoli

Bologna, Italy

Outcomes

Primary Outcomes

Rate of Implant Failure

Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication

Time frame: 24 months

Secondary Outcomes

Knee Related Adverse Events

Time frame: 24 months

Quality of repair tissue as assessed by magnetic resonance imaging

Time frame: at 24 months

Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire

Time frame: 24 months

Data from ClinicalTrials.gov

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