the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee
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|ClinicalTrials.gov Identifier: NCT02524509|
Recruitment Status : Unknown
Verified August 2015 by Sewon Cellontech Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : August 31, 2015
|Condition or disease|
|Defect of Articular Cartilage Articular Cartilage Disorder of Knee Degeneration; Articular Cartilage, Knee|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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 Knee Joint|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2015|
Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects
patients already underwent microfracture
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524509
|Korea, Republic of|
|Inha University Medical School Hospital|
|Incheon, Inchoen, Korea, Republic of|
|Principal Investigator:||Myung Goo Kim, MD||Inha University Medical School Hospital|