Clinical Trial: the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee

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

Official Title: An Inverstigational Clinical Trial for the Safety and Efficacy Evaluation of Chondron(Autologous Cultured Chondrocyte)Compared With Mircrofracture Surgery in Subjects With Cartilage Defects of the Kne

Brief Summary: The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.

Detailed Summary: It is an open clinical trial. Among the patients who received autologous cartilage cell graft using CHONDRON (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. During the clinical trial period, the subjects should follow the instruction of clinician in charge. Hospital visit is total 2 times* regularly. At the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, MRI test, and X-ray. If the selection time and the visit time are same, hospital visit will be one time*.
Sponsor: Sewon Cellontech Co., Ltd.

Current Primary Outcome: Score change of KOOS(Knee Injury and Osteoarthritis Outcome) [ Time Frame: Screening, post op 2years ]

comparison of the difference between a group with Chondron Implantation and a group with Microfracture.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Score change of 100 Vas(visual Analog System) [ Time Frame: Screening, post op 2years ]
    Comparison the difference between a group with Chondron Implantation and a group with Microfracture
  • Score change of IKDC (International Knee Documentation Committee) [ Time Frame: screening, post op 2 years ]
    comparison the difference between a group with Chondron Implantation and a group with Microfracture
  • Score change of KSS(Knee Society Score) [ Time Frame: Screening, Post op 2 years ]
    Comparision the difference between a group with Chondron Implantation and a group with Microfracture.
  • Comparing MRI results [ Time Frame: Screening, Post op 2years ]
    Comparison the difference of morphological improvement from MRI image between a group with Chondron Implantation and a group with Microfracture


Original Secondary Outcome:

  • Score change of 100 Vas(visual Analog System) [ Time Frame: Screening, post op 2years ]
    Comparison the difference between a group with Chondron Implantation and a group with Microfracture
  • Score change of IKDC (International Knee Documentation Committee) [ Time Frame: screening, post op 2 years ]
    comparison the difference between a group with Chondron Implantation and a group with Microfracture
  • Score change of KSS(Knee Society Score) [ Time Frame: Screening, Post op 2 years ]
    Comparision the difference between a group with Chondron Implantation and a group with Microfracture.
  • Comparing MRI results [ Time Frame: Screening, Post op 2years ]
    Comparison the difference between a group with Chondron Implantation and a group with Microfracture.


Information By: Sewon Cellontech Co., Ltd.

Dates:
Date Received: August 13, 2015
Date Started: January 2012
Date Completion: December 2015
Last Updated: August 28, 2015
Last Verified: August 2015