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

NCT01209390 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2011-09-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • TiGenix n.v.

    lead INDUSTRY

Principal Investigators

  • Laszlo Hangody, MD · Uzsoki Hospital, Budapest, Hungary

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-09-30
Completion
2016-04-30

Countries

  • Belgium
  • Germany
  • Hungary
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01209390 on ClinicalTrials.gov