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 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT04037228
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects aged over 18 years old
* All patients must provide their written consent
* patients with a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis who will receive a primary, posterior-stabilized TKA.
* All patients should have at least 8 years of school education;
* Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 or above
Exclusion Criteria:
* Patients are planned to receive a unicondylar or patellofemoral arthroplasty.
* Patients with previous cases of alcoholism or drug abuse;
* Pregnancy and breast-feeding;
* Presence of serious pathologies;
* revision surgery
* Knee infection
* Non-consenting patients who have not provided the written Informed Consent;
* Mechanical instability, ligamentous laxity/deficiency and gross deformity
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04037228
Study Brief:
Protocol Section:
NCT04037228