Transarterial microembolization (TAME) for inflamed knee osteoarthritis

"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology: Prospective Observational Study."

This project will try selective arterial embolization (TAME) to reduce chronic pain in adults with moderate inflammatory knee osteoarthritis who have not improved after at least three months of conservative care.

Quick facts

• Study type: Observational
• Enrollment: 43 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna, Bologna)
• Trial ID: NCT07140367 on ClinicalTrials.gov

What this trial studies

This observational study will enroll 43 patients with moderate (Kellgren-Lawrence grade 2-3) knee osteoarthritis with inflammatory features and persistent pain despite at least three months of conservative therapy. Enrolled patients will undergo transarterial microembolization (selective arterial embolization) and be followed with clinical evaluations at 1, 3, 6, 12, and 24 months or until dropout. Outcomes will focus on pain, functional status, and safety signals after the embolization procedure. The protocol uses multidisciplinary eligibility review and is conducted at IRCCS Istituto Ortopedico Rizzoli in Bologna.

Who should consider this trial

Good fit: Ideal candidates are adults over 40 with moderate (KL 2-3) knee osteoarthritis with inflammatory signs, persistent moderate-to-severe pain (VAS >4), and documented failure of at least three months of conservative therapies.

Not a fit: Patients with severe end-stage OA, rheumatic diseases, recent knee trauma, active malignancy, or other exclusion conditions listed by the investigators are less likely to benefit from this approach.

Why it matters

Potential benefit: If successful, the procedure could reduce knee pain and improve function, potentially delaying or reducing the need for knee replacement surgery.

How similar studies have performed: Related techniques such as genicular artery embolization have shown promising pain reduction in small series, but evidence remains limited and not yet definitive.

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.

Where this trial is running

Bologna, Bologna

• IRCCS Istituto Ortopedico Rizzoli — Bologna, Bologna, Italy (Recruiting)

Study contacts

• Study coordinator: Giancarlo Facchini, Medicine and Surgery

Conditions Inflammatory Articular Diseases; Knee Osteoarthristis; embolization; transarterial microembolization; TAME; arthritis; inflammatory articular disease; arthropathy