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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT07121556
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged between 18 and 75;
2. Radiographic evidence of bilateral OA of the knees graded between 2 and 4 on the Kellgren-Lawrence scale;
3. Pain equal to or greater than 4 on the Numeric Rating Scale (NRS) for both knees;
4. Failure, defined as persistence of symptoms after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment);
5. Ability and willingness to undergo the study procedures and comply with the instructions given by the study team; 6. No history of
4\. Failure, defined as persistent symptoms, after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment); 5. Ability and consent of patients to actively participate in the rehabilitation and follow-up protocol; 6. Signature of informed consent
Exclusion Criteria:
1. Patients incapable of understanding and willing;
2. Diagnosis of active neoplasia;
3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, active viral hepatitis; chondrocalcinosis;
4. Patients with uncontrolled diabetes mellitus;
5. Patients with uncontrolled thyroid metabolic disorders;
6. Patients who abuse alcohol, drugs, or medications;
7. Patients with lower limb misalignment greater than 5°;
8. Body Mass Index \> 35 kg/m2;
9. Pregnancy or breastfeeding, or plans to become pregnant during the study period .
10. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
11. Patients who have undergone knee surgery in the 12 months prior to screening.
12. Patients with insufficient abdominal adipose tissue, as assessed by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07121556
Study Brief:
Protocol Section:
NCT07121556