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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01050816 |
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Date of registration:
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13/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect
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Scientific title:
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An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01050816 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Gyeung Tea Lee, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eulji General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. adult men and women over 15 and less than 65 years of age
2. applied to patients with arthroscopically or grossly confirmed, partial cartilage
defect at the ankle joint
3. patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments,
bone defects at the cartilage defect area or patients who received correction in
advance.
4. patients which surrounding cartilage are normal
5. patients who agreed to clinical trial participation voluntarily or by the will of the
person in parental authority, and signed the written consent form
Exclusion Criteria:
1. patients hypersensitive to bovine protein
2. patients hypersensitive to gentamicin antibiotics
3. patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
4. patients with arthritis related to autoimmune disease
5. pregnant, breast-feeding patients or those who have a possibility of pregnancy
6. patients with accompanying diseases other than articular cartilage defects, including
tumors
7. patients who have a history of receiving radiotherapy, chemotherapy in the last 2
years
8. patients with diabetes (however, patients whose blood sugar test results are normal
and do not have any complication of diabetes, when a written opinion that CHONDRON
administration is possible is appended by a doctor are excluded)
9. patients who are administering antibiotics and antimicrobial agents due to infection
10. patients who receive steroid hormone therapy
11. Patients with psychiatric disorder and those who are considered to be inappropriate
for this trial by the judgment of the clinical trial manager
Age minimum:
15 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Articular Cartilage Defects of Ankle Joint
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Intervention(s)
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Procedure: Chondron(autologous chondrocyte) Implantation
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery
[Time Frame: baseline(preoperative stage),12months post-surgery]
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Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery
[Time Frame: baseline(preoperative stage),12months post-surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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