NCT03385642

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

Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Collagen Solutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Osteochondral Defect

Interventions

Type	Name	Description
DEVICE	ChondroMimetic	ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-02-22
• Completion: 2018-02-22
• First posted: 2017-12-28
• Last updated: 2018-04-17

Locations

1 site across 1 country: Hungary