Status:
COMPLETED
EAGLE European Post Market Study
Lead Sponsor:
Kensey Nash Corporation
Conditions:
Acute Knee Cartilage Injury
Tear of Articular Cartilage of Knee, Current
Eligibility:
All Genders
18+ years
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 des...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02309957
Start Date
May 1 2011
End Date
August 1 2019
Last Update
August 21 2019
Active Locations (6)
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1
University of Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
2
Technische Universität München
München, Germany
3
Klinikum der Universität Regensburg
Regensburg, Germany
4
Istituto Ortopedico Rizzoli
Bologna, Italy