Acute Knee Cartilage Injury, Tear of Articular Cartilage of Knee, Current
Conditions
Keywords
Knee Cartilage Repair, Osteochondral Defects, BioMatrix CRD
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.
Interventions
DEVICEBioMatrix CRD
Sponsors
Kensey Nash Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Implant Failure | 24 months | Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed