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

NCT02524509 | Unknown DMC

• 1 other identifier: 07CON
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Score change of 100 Vas(visual Analog System)

  Screening, post op 2years

• Score change of IKDC (International Knee Documentation Committee)

  screening, post op 2 years

• Score change of KSS(Knee Society Score)

  Screening, Post op 2 years

• Comparing MRI results

  Screening, Post op 2years

Study Arms (2)

CHONDRON

Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects

Microfracture

patients already underwent microfracture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total 50 patients. Patients who received autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) for knee osteoarthritis or patients underwent microfracture. There are total 28 patients who get CHONDRON grafting until now. Considering dropout rate, the selected number of investigational group is total 25, and 25 of equivalent control group is planned.

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sewon Cellontech Co., Ltd.: lead

Study Sites (1)

Inha University Medical School Hospital

Incheon, Inchoen, South Korea

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Myung Goo Kim, MD

  Inha University Medical School Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: January 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

KR (1)