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

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

Detailed Description
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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*.

Official Title
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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

Conditions
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Defect of Articular Cartilage, Articular Cartilage Disorder of Knee, Degeneration; Articular Cartilage, Knee

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1. Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago. 2. 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. 2. Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHONDRON<br>Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects | |
| Microfracture<br>patients already underwent microfracture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score change of KOOS(Knee Injury and Osteoarthritis Outcome) | comparison of the difference between a group with Chondron Implantation and a group with Microfracture. | Screening, post op 2years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chonodron, Microfracture, autologous cultured chondrocyte, cartilage defect of knee