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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209390
Recruitment Status : Terminated (Slow recruitment rate)
First Posted : September 27, 2010
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):
TiGenix n.v.

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

Condition or disease Intervention/treatment
Osteochondral Defects Device: Chondromimetic

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Study Type : Observational
Actual Enrollment : 8 participants
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
Study Start Date : September 2010
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : April 2016

Group/Cohort Intervention/treatment
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:
  • Osteochondral repair plug
  • CM

Primary Outcome Measures :
  1. Safety data [ Time Frame: on ongoing basis up to 3 years ]
    Safety data as measured by adverse device reactions

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01209390

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University Hospitals Leuven
Leuven, Belgium, 3001
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Uzsoki Hospital
Budapest, Hungary, 1145
United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
TiGenix n.v.
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Principal Investigator: Laszlo Hangody, MD Uzsoki Hospital, Budapest, Hungary
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Responsible Party: TiGenix n.v. Identifier: NCT01209390    
Other Study ID Numbers: OMCM-2010-01
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011
Keywords provided by TiGenix n.v.:
cartilage lesion
Additional relevant MeSH terms:
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Bone Diseases
Musculoskeletal Diseases