EAGLE European Post Market Study

NCT02309957 | Completed

• 1 other identifier: EAGLE EU Post Market Study
• Study Type: observational
• Target: 33
• Locations: 4 countries
• Sites: 6

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.

Conditions

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

Keywords

Knee Cartilage Repair, Osteochondral Defects, BioMatrix CRD

Outcome Measures

Primary Outcomes (1)

• Rate of Implant Failure

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

  24 months

Secondary Outcomes (3)

• 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

Study Arms (1)

BioMatrix CRD

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

Device: BioMatrix CRD

Interventions

BioMatrix CRD DEVICE

BioMatrix CRD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kensey Nash Corporation: lead

Study Sites (6)

University of Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Location

Technische Universität München

München, Germany

Location

Klinikum der Universität Regensburg

Regensburg, Germany

Location

Istituto Ortopedico Rizzoli

Bologna, Italy

Location

Maastricht University Medical Center (MUMC+)

Maastricht, Netherlands

Location

Robert Jones & Agnes Hunt Orthopaedic Hospital

Oswestry, United Kingdom

Location

Study Officials

• Justus Gille, PD Dr med

  University Hopsital Schleswig Holstein Campus Lübeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 5, 2014
• Study Start: May 1, 2011
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

DE (3); IT (1); GB (1); NL (1)