Status:
COMPLETED
Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC
Lead Sponsor:
Tetec AG
Collaborating Sponsors:
Aesculap AG
Winicker Norimed GmbH
Conditions:
Cartilage Diseases
Eligibility:
All Genders
18-55 years
Brief Summary
Retrospective, multicenter, single arm, non-interventional study to assess the safety and Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients treated for cart...
Detailed Description
This study is a multi-center, single arm, non-interventional study to assess the safety and performance of NOVOCART® Basic and the clinical outcome of MAC with NOVOCART® Basic in patients treated for ...
Eligibility Criteria
Inclusion
- for the biological reconstruction of localized full-layer cartilage damage (III and IV degree defects pursuant to the ICRS classification) in the knee joint.
- Treatable defects include:
- Cartilage damage caused by trauma
- Defects due to osteochondrosis dissecans
- Smaller focally-limited, degenerative cartilage damage
- Patients aged between 18 and 55 years
- Cartilage defect sizes from 1.5 to 4 cm²
- Deep osseous substance defects require prior osseous reconstruction. The indication should be confirmed using arthroscopy.
Exclusion
- Patients with known allergies to bovine collagen.
- Infected joints or infected wounds/areas near the joint, arthritis or inflammatory joint diseases of any type are contraindicated.
- More than two corresponding cartilage defects
- Instability of the knee, subtotal/total meniscus resection
- Varus/valgus malpositions (corrective surgery required in such cases)
- Haemorrhagic diathesis of various origins
- Applications which are not listed in the Indications section.
Key Trial Info
Start Date :
April 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03808623
Start Date
April 9 2018
End Date
July 24 2019
Last Update
April 2 2020
Active Locations (3)
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1
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Mannheim, Baden-Wurttemberg, Germany, 68165
2
Praxisklinik Rennbahn AG
Muttenz, Cantone of Basel-Landschaft, Switzerland, 4132
3
Cartilage Care
Bern, Cantone of Bern, Switzerland, 3012