Clinical trial NCT02309957: EAGLE European Post Market Study
Official title: Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Knee Cartilage Injury
Tear of Articular Cartilage of Knee, Current
Keywords: Knee Cartilage Repair, Osteochondral Defects, BioMatrix CRD
Lead sponsor: Kensey Nash Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Implant Failure
timeFrame: 24 months
Secondary outcomes:
measure: Knee Related Adverse Events
timeFrame: 24 months
measure: Quality of repair tissue as assessed by magnetic resonance imaging
timeFrame: at 24 months
measure: Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein, Campus Lübeck
city: München
country: Germany
facility: Technische Universität München
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC+)
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital
Study officials:
affiliation: University Hopsital Schleswig Holstein Campus Lübeck
name: Justus Gille, PD Dr med
role: PRINCIPAL_INVESTIGATOR
References: