Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions European Post Market Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. The patient is * 18 years old and skeletally mature (i.e. closed epiphyses).
2. The patient is male or a non-pregnant female who does not intend to become pregnant during the next 12 months.
3. The patient has a pre-procedure KOOS Pain subscale score is * 70.
4. The patient has an ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures 15mm in diameter. Note: only one knee per patient may be treated with BioMatrix CRD.
5. The cartilage lesion is amenable to treatment with a single BioMatrix CRD or an osteochondral autograft. Note: when an osteochondral autograft is harvested to repair the cartilage lesion, the harvest site defect is to be filled with BioMatrix CRD.
6. The patient has >= 50% of the meniscus remaining bilaterally with a stable rim.
7. The patient has the mental capacity and the willingness to comply with the post-operative rehabilitation plan, specified follow-up evaluations and can be contacted by telephone by site personnel.
8. The patient is willing and able to sign the informed consent document.

Exclusion Criteria

1. The patient is contraindicated for MRI (i.e. pacemaker, defibrillator, cochlear
2. The patient has had a previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended BioMatrix CRD implantation site. Note: patients having prior debridement only at the intended BioMatrix CRD implantation site are eligible.
3. The patient had surgery in the injured knee within the last 6 months.
4. The patient has clinically significant (> 5 degrees) varus or valgus malalignment in either knee. Note: concurrent osteotomy is permissible.
5. The patient has >= grade 2 joint space narrowing on the Kellgren-Lawrence scale.
6. The patient has documented history or peri-operative diagnosis of osteoarthritis in the injured knee.
7. The patient has inflammatory arthropathy (i.e., rheumatoid arthritis, systemic lupus or active gout) or any synovial proliferative disorder. Note: patients noted to have pseudogout are eligible.
8. The patient has osteomyelitis or other active infection in either lower limb.
9. The patient has had cortisone or hyaluronic acid knee injections in the past 3 months
10. The patient has a body mass index greater than 35.
11. The patient has a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol).
12. The patient was diagnosed with cancer within the last 2 years and received treatment with chemotherapy or received radiation therapy to the injured lower extremity.
13. The patient has a known allergy to the materials in the BioMatrix CRD.
14. The patient is currently involved in a study of an investigational product for a similar purpose.
15. The patient has a known co-morbidity that reduces life expectancy to less than 24 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the rate of implant failure resulting in device removal<br /><br>and/or further surgical intervention due to a device related complication<br /><br>through 24 months post operative.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Safety Endpoints:<br /><br>1. Rate of reparative tissue hypertrophy<br /><br>2. Rate of implant migration<br /><br>3. Rate of infection in the area of the implant<br /><br>4. Rate of individual adverse events attributable to the BioMatrix CRD implant<br /><br>5. Rate of serious adverse events associated with the surgical procedure<br /><br>Secondary Performance Endpoints:<br /><br>1. Rate of > 50% cartilage defect filling as assessed on the 24 month MRI scans.<br /><br>2. Rate of improvement in treated joint pain as measured on a KOOS Pain<br /><br>Subscale at each post-operative visit<br /><br>3. Rate of improvement in the IKDC score at each post-operative visit<br /><br>4. Rate of complete borderzone integration as assessed on the 24 month MRI<br /><br>scans</p><br>