Clinical Trial: Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Observational Study on the Feasibility, Safety and Efficacy in the Biological Reconstruction of the Hip Joint With Full Thickness Cartilage Defects With an in Situ Polymerizable and Chondrocyte Popula
Brief Summary: Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.
Detailed Summary:
Prospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with impingement syndrom in the hip.
Safety: 12-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions.
Efficacy: 12-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.
Sponsor: Tetec AG
Current Primary Outcome: Safety [ Time Frame: 12 months ]
Original Primary Outcome: Collecting evidence on the compatibility [ Time Frame: one year ]
Current Secondary Outcome: Efficacy [ Time Frame: 12 months ]
Original Secondary Outcome:
Information By: Tetec AG
Dates:
Date Received: June 27, 2014
Date Started: December 2014
Date Completion: April 2018
Last Updated: October 19, 2016
Last Verified: October 2016