NCT01209390

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

A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: TiGenix n.v. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Osteochondral Defects

Interventions

Type	Name	Description
DEVICE	Chondromimetic	The Chondromimetic implant is intended to serve as a scaffold for cellular and tissue ingrowth in osteochrondral defect repair such as bone and/or cartilage. The plug consists of a chondral layer with collagen and GAG and an osseus layer with collagen, GAG, and calcium phosphate.

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-09-01
• Completion: 2016-04-01
• First posted: 2010-09-27
• Last updated: 2011-09-20

Locations

4 sites across 4 countries: Belgium, Germany, Hungary, United Kingdom