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Completed

NCT Number: NCT02524509

the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Inha University Medical School Hospital

Incheon, Inchoen, South Korea

About this study

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*.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago.
  • Patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form

Exclusion criteria

  • 1. Patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial.
  • Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Cellontech Co., Ltd.

Industry

Registry information

Official study 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 Knee Joint

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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