EAGLE European Post Market Study

Acute Knee Cartilage Injury Clinical Trial

— EAGLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309957
• Other study ID #: EAGLE EU Post Market Study
• Status: Completed
• Start date: May 2011
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: Kensey Nash Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• BioMatrix CRD

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Kensey Nash Corporation

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knee Related Adverse Events		24 months
Secondary	Quality of repair tissue as assessed by magnetic resonance imaging		at 24 months
Secondary	Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire		24 months