EAGLE European Post Market Study

Completed

• Conditions: Tear of Articular Cartilage of Knee, Current; Acute Knee Cartilage Injury
• Interventions: Device: BioMatrix CRD

• Registration Number: NCT02309957
• Lead Sponsor: Kensey Nash Corporation

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Status Verified: 2019-08
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of Implant Failure	24 months	Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication

Secondary Outcome Measures

Name	Time	Method
Knee Related Adverse Events	24 months
Quality of repair tissue as assessed by magnetic resonance imaging	at 24 months
Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire	24 months

Trial Locations

Locations (6)

University of Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Germany

Klinikum der Universität Regensburg; 🇩🇪 Regensburg, Germany

Technische Universität München; 🇩🇪 München, Germany

Robert Jones & Agnes Hunt Orthopaedic Hospital; 🇬🇧 Oswestry, United Kingdom

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy

Maastricht University Medical Center (MUMC+); 🇳🇱 Maastricht, Netherlands