Postmarketing study to review functionality, tolerability and safety of collagen based implants (Chondrofiller liquid) for treatment of severe cartilage defects in the knee joint (level 3-4)
- Conditions
- M94.26M94.97
- Registration Number
- DRKS00009703
- Lead Sponsor
- meidrix biomedicals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 68
• Intact cartilage shoulder
• Intact surrounding cartilage
• Intact corresponding joint surface (damage of up to grade II according to Outerbridge is allowed)
• Intact meniscus (partial resection up to not more than 1/3 of the total volume is allowed)
• Intact ligaments, physiological mechanical axis
• Unrestricted joint flexibility
• Patients in a state of health acceptable for undergoing general anesthesia
• Defect grade III and IV according to Outerbridge
• Defect localization: knee, shoulder and upper ankle joints
• Hypersensitivity and/or allergy to collagen
• Unicompartimental arthrosis
• Multicompartimental arthrosis
• Hematopoetic disorders
• Malignant diseases
• Neurological diseases
• Increased risk of bleeding
• Pregnant or breastfeeding women
• Patients incapable of contracting or detained patients
• Joint stiffness
• Arthrofibrosis
• Infections of the joints
• Metabolic diseases
• Genu varum of >5°
• Contra-indications for MRI examinations
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the IKDC Score and an improvement over 6 and 36 months.
- Secondary Outcome Measures
Name Time Method • MOCART Score (1 year and 3 years)<br>• Global assessment (1 – 5) <br>• Quality of life <br>• Patient/user satisfaction<br>• Safety