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:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT02539056
Eligibility Criteria:
Inclusion Criteria:
1. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) \* For a single lesion, less than 15 cm2 cartilage defects; and for multiple lesions, less than 20 cm2
2. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
3. Patients which surrounding cartilage are normal
4. Patients who were 15 years old or older
5. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed 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 (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
7. Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
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 with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
10. Patients under adrenocorticoid therapy (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
12. Patients with cartilage defects in both knees (If the necessity of other surgery on the opposite side of knee joint using Chondron is confirmed with doctor's clinical decision).
13. Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment. Hypertension patients are allowed.)
14. Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment.)
15. Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT02539056
Study Brief:
Protocol Section:
NCT02539056