Clinical Trial: Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects

Brief Summary: Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.

Detailed Summary: A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.
Sponsor: Tetec AG

Current Primary Outcome: Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety [ Time Frame: 36 month ]

Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety


Original Primary Outcome: Safety - Number of Participants with Adverse Effects as a Measure of Safety [ Time Frame: 36 month ]

Number of Participants with Adverse Effects as a Measure of Safety


Current Secondary Outcome: Efficacy - International Knee Documentation Committee (IKDC) 2000 [ Time Frame: 36 month ]

International Knee Documentation Committee (IKDC) 2000


Original Secondary Outcome: Same as current

Information By: Tetec AG

Dates:
Date Received: January 13, 2015
Date Started: June 2015
Date Completion: September 2019
Last Updated: October 19, 2016
Last Verified: October 2016