- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01209390
A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects (OMCM)
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3001
- University Hospitals Leuven
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Freiburg, Germany, 79106
- Universitatsklinikum Freiburg
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Budapest, Hungary, 1145
- Uzsoki Hospital
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Cambridge, United Kingdom, CB2 0QQ
- Addenbrookes Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Exclusion Criteria:
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative joint disease
- Pregnancy
- Presence of infection at the site or in the joint space (e.g. osteomyelitis)
- Diagnosis rheumatoidism
- Advanced osteoarthritis as judged by the surgeon
- Drug and/or alcohol abuse
- Hypercalcemia
- Known allergy to any of the components of the device (e.g. bovine collagen)
- Bleeding disorders of any etiology
- Steroidal or immunosuppressive maintenance therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Osteochondral lesions
Patients with osteochondral lesions in the knee, the ankle, or other joint
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Safety data
Time Frame: on ongoing basis up to 3 years
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Safety data as measured by adverse device reactions
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on ongoing basis up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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EuroQoL-5D
Time Frame: baseline, 6, 12, 24, 36 months
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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
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baseline, 6, 12, 24, 36 months
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MRI
Time Frame: baseline, 12, 24, 36 months
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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.
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baseline, 12, 24, 36 months
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Failure rate
Time Frame: 3 years
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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.
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laszlo Hangody, MD, Uzsoki Hospital, Budapest, Hungary
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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.
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Askel Healthcare LtdRecruitingCartilage or Osteochondral Defects in the KneeEstonia, Finland, Sweden
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Cartiheal (2009) LtdCompletedCartilage or Osteochondral Defects in the KneeAustria, Belgium, Slovenia, Italy, Israel, Poland, Romania, Serbia
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Collagen SolutionsCompleted
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Fundació Institut de Recerca de l'Hospital de la...Banc de Sang i TeixitsRecruitingOsteochondral DefectSpain
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Medical University of ViennaSurgebright GmbhRecruitingOsteochondral DefectAustria
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NuTech Medical, IncOrganogenesisTerminated
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Jordi Villalba ModolUnknownChondral Defect | Osteochondral DefectSpain
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University Hospital, BrestInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedKnee Chondral or Osteochondral DefectFrance
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Academisch Medisch Centrum - Universiteit van Amsterdam...Terminated
Clinical Trials on Chondromimetic
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