Trial Outcomes & Findings for Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect (NCT NCT01050816)

Last Updated: 2010-05-11

Results Overview

AOFAS scores(best score-100,worst score- 0 ) 1. pain-none:40/Strong and Always present:O 2. Function * 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 3. alignment- good:10/bad:0

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

baseline(preoperative stage),12months post-surgery

Results posted on

2010-05-11

Participant Flow

30 subjects who have ankle cartilage defects

Participant milestones

Participant milestones
Measure	Chondron Implantation Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Chondron Implantation Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Overall Study Lost to Follow-up	2
Overall Study patient's refusal	2

Baseline Characteristics

Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chondron Implantation n=30 Participants Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	36.67 years STANDARD_DEVIATION 11.44 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment Korea, Republic of	30 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline(preoperative stage),12months post-surgery

Population: Among the 30 patients, 27 who received CHONDRON transplantation became subjects for Full Analysis Set(FAS) analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)

Outcome measures

Outcome measures
Measure	Chondron Implantation n=27 Participants Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery	16.93 scores Standard Deviation 13.04

SECONDARY outcome

Timeframe: baseline(preoperative stage),12months post-surgery

Population: Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)

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.

Outcome measures

Outcome measures
Measure	Chondron Implantation n=27 Participants Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery	-27.19 mm Standard Deviation 31.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chondron Implantation n=27 Participants Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery	26.26 scores Standard Deviation 18.07

Adverse Events

Chondron Implantation

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chondron Implantation n=30 participants at risk Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Musculoskeletal and connective tissue disorders malleolar ostoeotomy nonunion	6.7% 2/30 • Number of events 3 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.

Other adverse events

Other adverse events
Measure	Chondron Implantation n=30 participants at risk Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Gastrointestinal disorders nausea	26.7% 8/30 • Number of events 8 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders dyspepsia	6.7% 2/30 • Number of events 4 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders vomiting	6.7% 2/30 • Number of events 2 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders epigastric soreness'	10.0% 3/30 • Number of events 3 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders abdominal pain	6.7% 2/30 • Number of events 2 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders gastritis	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders polyp	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders constipation	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders diarrhea	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Gastrointestinal disorders defecation disorder'	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Musculoskeletal and connective tissue disorders pain	33.3% 10/30 • Number of events 19 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Musculoskeletal and connective tissue disorders malleolar osteotomy site pain	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Musculoskeletal and connective tissue disorders lower extremities numbness	6.7% 2/30 • Number of events 2 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Musculoskeletal and connective tissue disorders sholuder pain	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Musculoskeletal and connective tissue disorders lower extremities pain	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Renal and urinary disorders dysuria	6.7% 2/30 • Number of events 2 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Renal and urinary disorders testicular pain	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Renal and urinary disorders proteinuria	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
General disorders edema	6.7% 2/30 • Number of events 5 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
General disorders headache	13.3% 4/30 • Number of events 6 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
General disorders Fever	6.7% 2/30 • Number of events 2 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Psychiatric disorders insomnia	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Nervous system disorders vertigo	3.3% 1/30 • Number of events 1 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Skin and subcutaneous tissue disorders eczema	6.7% 2/30 • Number of events 2 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	6.7% 2/30 • Number of events 3 • Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery. Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.

Additional Information

Lee Gyeong Tae

Eulji General Hospital

Phone: +82-11-214-3323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60