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:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01282034
Eligibility Criteria:
Inclusion Criteria:
1. Patients provided written informed consent;
2. Patients aged between 18 and 60 years;
3. Knee symptomatic chondral lesion of grade III/IV (according to Outerbridge Classification) or osteochondral lesion;
4. Not re-fixable OCD lesions;
5. Lesion between 2-9 cm2;
6. Single lesion;
7. Patients agreed to actively participate in the rehabilitation protocol and follow-up program;
8. Male or female patients;
9. Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment.
Exclusion Criteria:
1. Patients incapable to understanding and will;
2. Patients participating in previous, concurrent or not, trials (ongoing or completed within 3 months);
3. Patients surgically treated for the same defect within one year;
4. Known allergy to collagen or calcium-phosphates;
5. Patients affected by malignancy;
6. Patients affected by metabolic or thyroid disorders;
7. Patients used to alcohol or drug (medication) abuse;
8. Patients affected by advanced osteoarthritis (Kellgren-Lawrence grade ≥3);
9. Patients affected by synovitis;
10. Untreated patellofemoral malalignment;
11. Varus or valgus malalignment exceeding 5°;
12. Body Mass Index \> 30;
13. Patients previously treated for total or partial meniscectomy (\>50% of the meniscus dimension);
14. Multiple lesions;
15. Kissing lesions;
16. Chondral/osteochondral tibial plate defects;
17. Concomitant menisci and chondral/osteochondral defects to be treated;
18. Untreated knee ligament instability.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01282034
Study Brief:
Protocol Section:
NCT01282034