Cartilage Defect Clinical Trial
Official title:
Pivotal Study in Europe for CE Mark
Verified date | July 2017 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.
Status | Terminated |
Enrollment | 21 |
Est. completion date | December 2012 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - A standing radiograph of the knee showing a Kellgren score of 0-2 - Body mass index =33 - An Outerbridge score of III or IV without need for bone graft - A meniscus with no more than partial resection in the affected knee Exclusion Criteria: - Passive motion deficit of the knee (>5º of extension, >15º of flexion) - Moderate or severe osteoarthritis - Diabetes mellitus (IDDM Type 1) - Patellofemoral instability - Malalignment with > 5° valgus or varus compared to contralateral knee - Active osteomyelitis |
Country | Name | City | State |
---|---|---|---|
Austria | Medalp | Imst | |
Austria | Ortho.Abteilung, AKH Linz | Linz | |
Germany | Krakenhaus Altentreptow | Altentreptow | |
Germany | Orthopedic and Pain Center Freiberg | Freiberg | |
Germany | University Mannheim | Mannheim | |
Netherlands | Meander Medical Center | Baarn | |
Netherlands | Tergooiziekenhuizen | Hilversum |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Austria, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Defect fill at 6 months determined by magnetic resonance imaging (MRI) | 6 months | ||
Secondary | Pain score (VAS) | 6 months | ||
Secondary | Knee function as assessed by the IKDC questionnaire | 6 months | ||
Secondary | SF-36 Health Survey | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03672825 -
REcycled CartiLage Auto/Allo IMplantation
|
Phase 1 | |
Recruiting |
NCT05553132 -
A Study of REcycled CartiLage Auto/Allo IMplantation to Treat and Repair Focal Hip Cartilage Defects
|
Phase 1 |