Clinical Trial: Evaluation of the Agili-C Biphasic Implant in the Knee Joint

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

Official Title: Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects

Brief Summary: The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.

Detailed Summary: Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.
Sponsor: Cartiheal (2009) Ltd

Current Primary Outcome: improvement in KOOS pain subscales [ Time Frame: 24 months ]

The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale


Original Primary Outcome: improvement in KOOS pain subscales [ Time Frame: 24 months ]

Current Secondary Outcome: KOOS total score [ Time Frame: 24 months ]

  • Change from baseline to 3, 6, 9, 12, 18 and 24 months visits as measured by the KOOS total score and subscales.
  • Change from baseline to 18 and 24 months visit in IKDC current health assessment.
  • Change from baseline to 3, 6, 12, 18 and 24 months visit in Lysholm with Tegner knee score.
  • Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC knee examination form 2000
  • Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC subjective knee evaluation
  • Change in MOCART scoring as measured at 3, 6, 12 , 18 and 24 months visit


Original Secondary Outcome:

Information By: Cartiheal (2009) Ltd

Dates:
Date Received: November 10, 2011
Date Started: June 2011
Date Completion: December 2018
Last Updated: February 28, 2017
Last Verified: February 2016