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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02524509

Enrollment

Registered

2015-08-14

Start date

2012-01-01

Completion date

2016-09-01

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Chonodron, Microfracture, autologous cultured chondrocyte, cartilage defect of knee

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 description

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\*.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Score change of 100 Vas(visual Analog System)	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)	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)	Screening, Post op 2 years	Comparision the difference between a group with Chondron Implantation and a group with Microfracture.
Comparing MRI results	Screening, Post op 2years	Comparison the difference of morphological improvement from MRI image between a group with Chondron Implantation and a group with Microfracture

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORMyung Goo Kim, MD

Inha University Medical School Hospital

Outcome results