A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects (OMCM)

TiGenix

Status: Terminated

Conditions: Osteochondral Defects

Treatments: Device: Chondromimetic

Study type: Observational

Funder types: Industry

Identifiers

NCT01209390

OMCM-2010-01

Details and patient eligibility

About

The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.

The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.

The secondary objectives are:

• Clinical outcome as assessed by patient reported EuroQoL-5D
• Structural repair as assessed by MRI
• The number of treatment failures and the time to treatment failure
• The ease of use of ChondroMimetic as reported by the surgeon

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed patient informed consent
2. Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area
3. Agree to actively participate in a rehabilitation protocol

Exclusion criteria

1. Severe vascular or neurological disease
2. Uncontrolled diabetes
3. Severe degenerative joint disease
4. Pregnancy
5. Presence of infection at the site or in the joint space (e.g. osteomyelitis)
6. Diagnosis rheumatoidism
7. Advanced osteoarthritis as judged by the surgeon
8. Drug and/or alcohol abuse
9. Hypercalcemia
10. Known allergy to any of the components of the device (e.g. bovine collagen)
11. Bleeding disorders of any etiology
12. Steroidal or immunosuppressive maintenance therapy

Trial design

8 participants in 1 patient group

Osteochondral lesions

Description:

Patients with osteochondral lesions in the knee, the ankle, or other joint

Treatment:

Device: Chondromimetic