Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee

Collagen Solutions

Status: Completed

Conditions: Osteochondral Defect

Treatments: Device: ChondroMimetic

Study type: Observational

Funder types: Industry

Identifiers

NCT03385642

0MCM0107-2

Details and patient eligibility

About

To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.

Full description

This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.

Trial design

15 participants in 1 patient group

Chondromimetic

Description:

Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107

Treatment:

Device: ChondroMimetic