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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT06040957
Eligibility Criteria:
Inclusion Criteria:
Patients with symptomatic unilateral knee OA with:
1. Men or women aged 40 to 75 years;
2. Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months;
3. Radiographic signs of OA (Kellgren-Lawrence grade 1-4);
4. No benefit after at least 4 months of conservative treatment;
5. Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up;
6. Signing of informed consent.
Exclusion Criteria:
1. Patients unable to express consent;
2. Patients aged \< to 40 and \> to 75 years;
3. Patients with axial deviations \> 5°;
4. Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months;
5. Patients who have undergone knee surgery in the previous 12 months;
6. Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries);
7. Patients with malignant neoplasms;
8. Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases);
9. Patients with infectious diseases;
10. Patients with histories of alcohol or drug abuse;
11. Patients who are pregnant;
12. Patients with allergies to anesthetics used in the procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT06040957
Study Brief:
Protocol Section:
NCT06040957