Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect
|Articular Cartilage Defects of Ankle Joint||Procedure: Chondron(autologous chondrocyte) Implantation||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect|
- Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]
AOFAS scores(best score-100,worst score- 0 )
- pain-none:40/Strong and Always present:O
- activities-without support activities:10/need restrain, clutch , walker or wheelchair:0
- Maximum gait distance- more than 6:5/ less than 1:0
- gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0
- Gait abnormality-none:8/marked:0
- saggital mobidity- normal or minimal restrain:6/strong restraint:0
- hindfoot mobidity -normal minimal restrain:6/strong restrain:0
- ankle and hindfoot stability - stable:8/unstable:0
- alignment- good:10/bad:0
- Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]
A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point.
- Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]The Modified Hannover Score System contains information about patient's status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.
|Study Start Date:||January 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Chondron implantation
ankle cartilage defect patients who had CHONDRON transplantation
Procedure: Chondron(autologous chondrocyte) Implantation
Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected.
*30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation.
Other Name: Chondron
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050816
|Korea, Republic of|
|Seoul, Sungdong-ku, Korea, Republic of, 133831|
|Principal Investigator:||Gyeung Tea Lee, MD||Eulji General Hospital|