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Recruiting Observational

"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"

NCT07140367 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-09-01
Last updated
2026-04-07

Condition(s) studied

Inflammatory Articular DiseasesKnee Osteoarthristis

Investigational drug(s) / intervention(s)

Transarterial Microembolization

Transarterial Microembolization: Identification of the hypervascularization of the knee. Selective and super-selective catheterization of pathological genicular arterial branches, through the use of micro-catheters. - Injection of embolizing material (Nexsphere-F - Kardia) - Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature).

Study 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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Reduction of pain (VAS score) — 1 year
    Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Istituto Ortopedico Rizzoli Bologna Bologna Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07140367 on ClinicalTrials.gov ↗ ← All trials in Italy