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 ]
Original Primary Outcome: Safety - Number of Participants with Adverse Effects as a Measure of Safety [ Time Frame: 36 month ]
Current Secondary Outcome: Efficacy - International Knee Documentation Committee (IKDC) 2000 [ Time Frame: 36 month ]
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