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 ]

Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.


Original Primary Outcome: Collecting evidence on the compatibility [ Time Frame: one year ]

The primary objective of the Observation is to collect evidence about the effectiveness of the method and NOVOCART ® Inject in the context of the known safety profile when used as intended. The detection is carried out post-operatively by documentation of adverse events or side effects following the use of NOVOCART ® Inject up to 12 months.


Current Secondary Outcome: Efficacy [ Time Frame: 12 months ]

Outcome of iHOT 33 and EuroQuol-5D-5L as a measurement of function and Quality of life


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