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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07140367
Eligibility Criteria:
Inclusion Criteria:
\- Patients with degenerative knee disease:
1. Age over 40 years;
2. Moderate knee OA (grade 2-3 according to the Kellgren-Lawrence score) for which an indication for total knee arthroplasty surgery has already been given;
3. Knee OA with an inflammatory component (night pain, pain at rest, recurrent episodes of effusion, swelling and/or redness);
4. Persistent and moderate or severe knee pain (VAS score \> 4);
5. Failure after at least 3 months of conservative therapies (e.g., physical therapy, drug therapy with NSAIDs and pain relievers, hyaluronic acid infiltration, corticosteroids, or orthobiologics).
6. Signature of informed consent
7. Case declared eligible for treatment following discussion at internal multidisciplinary meeting on degenerative-inflammatory disease
Exclusion Criteria:
1. Mentally incompetent patients;
2. Patients with trauma in the 6 months prior to treatment;
3. Patients with malignant neoplasms;
4. Patients with rheumatic diseases;
5. Patients on anticoagulant-antiaggregant therapy (including if therapy can be discontinued 5 days earlier);
6. Patients abusing alcoholic beverages, drugs, or medications;
7. Patients undergoing surgery of the affected knee in the previous 12 months;
8. INR \<2;
9. Platelet count \<30,000;
10. Renal function: GFR\<30ml/min;
11. Pregnancy;
12. Allergy to iodinated contrast.
13. Ineligibility to perform MRI examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07140367
Study Brief:
Protocol Section:
NCT07140367