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

Osteochondral Defects Clinical Trial

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

Status Terminated

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteochondral Defects

• NCT number: NCT01209390
• Study type: Observational
• Source: TiGenix n.v.
• Status: Terminated
• Phase: N/A
• Start date: September 2010
• Completion date: April 2016