Status:
TERMINATED
A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
Lead Sponsor:
TiGenix n.v.
Conditions:
Osteochondral Defects
Eligibility:
All Genders
18-65 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01209390
Start Date
September 1 2010
End Date
April 1 2016
Last Update
September 20 2011
Active Locations (4)
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1
University Hospitals Leuven
Leuven, Belgium, 3001
2
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
3
Uzsoki Hospital
Budapest, Hungary, 1145
4
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ