M94.26 M94.97
Conditions
Interventions
Group 1: In this non-interventional study the routine treatment with the Chondrofiller in the knee will be observed. For this, following scores will be used: (SF-36, IKDC [subjective knee Evaluation f
Sponsors
meidrix biomedicals GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the IKDC Score and an improvement over 6 and 36 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • MOCART Score (1 year and 3 years) • Global assessment (1 – 5) • Quality of life • Patient/user satisfaction • Safety | — |
Countries
Germany
Contacts
Public ContactUlrich Schneider
Diakonie Krankenhaus München
Outcome results
None listed