EAGLE European Post Market Study (EAGLE)

August 20, 2019 updated by: Kensey Nash Corporation

Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lübeck, Germany
        • University of Schleswig-Holstein, Campus Lübeck
      • München, Germany
        • Technische Universität München
      • Regensburg, Germany
        • Klinikum der Universität Regensburg
  • Italy
      • Bologna, Italy
        • Istituto Ortopedico Rizzoli
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center (MUMC+)
  • United Kingdom
      • Oswestry, United Kingdom
        • Robert Jones & Agnes Hunt Orthopaedic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Observational study of patients receiving BioMatrix CRD for surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BioMatrix CRD
All patients will receive BioMatrix CRD to repair an articular cartilage lesion or osteochondral defect.
Device: BioMatrix CRD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Implant Failure
Time Frame: 24 months
Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee Related Adverse Events
Time Frame: 24 months
24 months
Quality of repair tissue as assessed by magnetic resonance imaging
Time Frame: at 24 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kensey Nash Corporation

Investigators

  • Principal Investigator: Justus Gille, PD Dr med, University Hopsital Schleswig Holstein Campus Lübeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EAGLE EU Post Market Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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