NCT07140367 "Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"
| NCT ID | NCT07140367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Inflammatory Articular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 43 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 43 participants in total. It began in 2025-09-01 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization, follow-up checks). Forty-three patients will be included in the study and will undergo the transarterial microembolization procedure after signing the informed consent form for participation in the study and the collection of anamnestic data. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12, and 24 months of follow-up or until possible dropout for other treatment.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07140367 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Inflammatory Articular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07140367 currently recruiting?
Yes, NCT07140367 is actively recruiting participants. Contact the research team at giancarlo.facchini@ior.it for enrollment information.
Where is the NCT07140367 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07140367 clinical trial?
NCT07140367 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 43 participants.