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

TiGenix n.v.4 sites in 4 countries8 target enrollmentSeptember 2010

ConditionsOsteochondral Defects

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteochondral Defects
Sponsor: TiGenix n.v.
Enrollment: 8
Locations: 4
Primary Endpoint: Safety data
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

April 2016

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

TiGenix n.v.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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