Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT01056900
Eligibility Criteria:
* Inclusion Criteria:
1. Adult males and females aged between 15 and 65
2. Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually
3. Patients with misalignment between tibia and talus of the ankle joint, lateral ankle instability, and a bony defect in the cartilaginous defect or who had a correction simultaneously or in advance
4. Patients whose surrounding cartilage is normal
5. Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial
* Exclusion Criteria:
1. Patients hypersensitive to bovine protein
2. Patients hypersensitive to antibiotics like gentamicin
3. Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis
4. Patients with arthritis associated with autoimmune diseases
5. Patients who are pregnant, nursing a baby or likely to get pregnant
6. Patients with other diseases including tumors except for cartilaginous defects of joints
7. Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy
8. Diabetics (however, patients who were normal in the blood glucose test and have no complication due to diabetes will be excluded if the doctor says Chondron can be administered to them)
9. Patients with infections who are taking antibiotics and antimicrobial agents
10. Patients who are treated with adrenal cortical hormones
11. Patients whom the investigators find to be unfit for this clinical trial, such as mental patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
65 Years
Study:
NCT01056900
Study Brief:
Protocol Section:
NCT01056900