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

September 19, 2011 updated by: TiGenix n.v.

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

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

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3001
        • University Hospitals Leuven
      • Freiburg, Germany, 79106
        • Universitatsklinikum Freiburg
      • Budapest, Hungary, 1145
        • Uzsoki Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited in selected centres, primary or secondary care, first line or referral treatment.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe vascular or neurological disease
  2. Uncontrolled diabetes
  3. Severe degenerative joint disease
  4. Pregnancy
  5. Presence of infection at the site or in the joint space (e.g. osteomyelitis)
  6. Diagnosis rheumatoidism
  7. Advanced osteoarthritis as judged by the surgeon
  8. Drug and/or alcohol abuse
  9. Hypercalcemia
  10. Known allergy to any of the components of the device (e.g. bovine collagen)
  11. Bleeding disorders of any etiology
  12. Steroidal or immunosuppressive maintenance therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Osteochondral lesions
Patients with osteochondral lesions in the knee, the ankle, or other joint

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.

Other Names:
  • CM
  • Osteochondral repair plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety data
Time Frame: on ongoing basis up to 3 years
Safety data as measured by adverse device reactions
on ongoing basis up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQoL-5D
Time Frame: baseline, 6, 12, 24, 36 months
The EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension
baseline, 6, 12, 24, 36 months
MRI
Time Frame: baseline, 12, 24, 36 months
Structural repair will be assessed by MRI. The available MRIs will be collected and scored by an independent radiologist, using the published MOCART score , and one additional item, level of the subchondral bone plate.
baseline, 12, 24, 36 months
Failure rate
Time Frame: 3 years
Treatment failure is defined as "a re-intervention on the index lesion, prompted by persistence or recurrence of symptoms related to the index knee". The date of failure is the actual date of re-intervention.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Laszlo Hangody, MD, Uzsoki Hospital, Budapest, Hungary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2015

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (ESTIMATE)

September 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2011

Last Update Submitted That Met QC Criteria

September 19, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMCM-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteochondral Defects

Clinical Trials on Chondromimetic

3
Subscribe