Clinical Trial: Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® I
Brief Summary: Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.
Detailed Summary:
Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.
Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.
Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).
Sponsor: Tetec AG
Current Primary Outcome: Number of adverse drug reaction/serious adverse drug reaction [ Time Frame: Up to 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Outcome of IKDC 2000 [ Time Frame: Up to 24 months ]Outcome of the IKDC 2000 as measurements of symptoms and function
- Outcome of KOOS [ Time Frame: Up to 24 months ]Outcome of KOOS as measurements of symptoms and function
Original Secondary Outcome: Same as current
Information By: Tetec AG
Dates:
Date Received: October 18, 2016
Date Started: December 2015
Date Completion: July 2017
Last Updated: October 19, 2016
Last Verified: October 2016