Clinical Trial: Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)

Brief Summary: Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Detailed Summary:

Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.

The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant


Sponsor: Cartiheal (2009) Ltd

Current Primary Outcome: • The KOOS Pain Subscale relative to baseline [ Time Frame: 24 Months ]

The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m


Original Primary Outcome: • Improvement in KOOS Pain Subscale. [ Time Frame: 24 Months ]

The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m


Current Secondary Outcome:

  • • Improvement in other KOOS subscales relative to baseline [ Time Frame: 24 Months ]

    Other KOOS subscales are evaluated at 6m, 12m, 18m & 24m •

    •

  • • Improvement in IKDC Subjective Knee Score relative to baseline [ Time Frame: 24 Months ]
    IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m & 24m
  • • Improvement in SF-36 Survey [ Time Frame: 24 Months ]
    SF-36 Survey is evaluated at 6m, 12m, 18m & 24m
  • • Improvement in Tegner Score [ Time Frame: 24 Months ]
    Tegner Score is evaluated at 6m, 12m, 18m & 24m
  • • Improvement in Lysholm Knee Scoring Scale [ Time Frame: 24 Months ]
    Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m & 24m
  • • Joint Space maintenance rate according to X-ray [ Time Frame: 24 Months ]
    Joint Space maintenance rate is evaluated at 12m & 24m
  • • Defect Fill according to MRI [ Time Frame: 24 Months ]
    Defect Fill according to MRI is evaluated at 6m, 12m, 18m & 24m
  • Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline [ Time Frame: 24 mMonths ]
    The KOOS Overall is evaluated at 6, 12,18 and 24 months


Original Secondary Outcome:

  • Improvement in KOOS Score and Subscales [ Time Frame: 24 Months ]
    • Improvement in KOOS Score and Subscales.
  • Improvement in IKDC Subjective Knee Score (and VAS as part of it) . [ Time Frame: 24 Months ]
    Improvement in IKDC Subjective Knee Score (and VAS as part of it) .
  • Improvement in IKDC Knee Examination Form - 2000 [ Time Frame: 24 Months ]
    Improvement in IKDC Knee Examination Form - 2000
  • Improvement in the SF-36 Questionnaire. [ Time Frame: 24 Months ]
    Improvement in the SF-36 Questionnaire.
  • Improvement in Tegner Score. [ Time Frame: 24 Months ]
    Improvement in Tegner Score.
  • Improvement in Lysholm Knee Scoring Scale. [ Time Frame: 24 Months ]
    Improvement in Lysholm Knee Scoring Scale.
  • Improvement in MOCART Scoring [ Time Frame: 24 Months ]
    Improvement in MOCART Scoring


Information By: Cartiheal (2009) Ltd

Dates:
Date Received: December 3, 2014
Date Started: May 2014
Date Completion: March 2020
Last Updated: August 14, 2016
Last Verified: August 2016