Transarterial microembolization (TAME) for inflamed knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Istituto Ortopedico Rizzoli
  Bologna, Bologna, Italy Recruiting

Study contacts

• Study coordinator: Giancarlo Facchini, Medicine and Surgery
• Email: giancarlo.facchini@ior.it
• Phone: +39 0516366836

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.