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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02941120
Eligibility Criteria:
Inclusion Criteria:
* male and female patients
* juvenile patients with closed epiphysial plate
* insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
* defect size ≥ 2.5 and ≤ 10 cm2
* intact or reconstructed bony subchondral plate
* in the case of deep bony substance defects, additional bony reconstruction is needed
Exclusion Criteria:
* radiographic signs of osteoarthritis of Kellgren and Lawrence \> 2
* joint stiffness
* arthrofibrosis
* malalignment in the knee (valgus- or varus deformity) \> 3° (correction contemporary to the ACT)
* insufficient reconstructed ligaments (correction contemporary to the ACT)
* defective position patella (correction contemporary to the ACT)
* sled prosthesis implants or carbon pin
* inflammatory joint diseases (f.e. rheumatoid arthritis)
* corresponding cartilage defects ("kissing lesions")
* more than two independent cartilage defects in one knee
* primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate
* diffuse chondromalacia
* congenital or gained deformity of patella
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
50 Years
Study:
NCT02941120
Study Brief:
Protocol Section:
NCT02941120