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

This study has been terminated.
(Slow recruitment rate)
Sponsor:
Information provided by (Responsible Party):
TiGenix n.v.
ClinicalTrials.gov Identifier:
NCT01209390
First received: August 6, 2010
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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

Condition Intervention
Osteochondral Defects
Device: Chondromimetic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects

Further study details as provided by TiGenix n.v.:

Primary Outcome Measures:
  • Safety data [ Time Frame: on ongoing basis up to 3 years ] [ Designated as safety issue: Yes ]
    Safety data as measured by adverse device reactions


Secondary Outcome Measures:
  • EuroQoL-5D [ Time Frame: baseline, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
    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

  • MRI [ Time Frame: baseline, 12, 24, 36 months ] [ Designated as safety issue: No ]
    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.

  • Failure rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 8
Study Start Date: September 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Osteochondral lesions
Patients with osteochondral lesions in the knee, the ankle, or other joint
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.

Other Names:
  • Chondromimetic
  • Osteochondral repair plug
  • CM

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209390

Locations
Belgium
University Hospitals Leuven
Leuven, Belgium, 3001
Germany
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Hungary
Uzsoki Hospital
Budapest, Hungary, 1145
United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
TiGenix n.v.
Investigators
Principal Investigator: Laszlo Hangody, MD Uzsoki Hospital, Budapest, Hungary
  More Information

No publications provided

Responsible Party: TiGenix n.v.
ClinicalTrials.gov Identifier: NCT01209390     History of Changes
Other Study ID Numbers: OMCM-2010-01
Study First Received: August 6, 2010
Last Updated: September 19, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by TiGenix n.v.:
osteochondral
regenerative
repair
cartilage lesion

Additional relevant MeSH terms:
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014