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 ]

Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety


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