"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"
Recruiting · NCT07140367 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- \- Patients with degenerative knee disease:
- Age over 40 years;
- 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;
- Knee OA with an inflammatory component (night pain, pain at rest, recurrent episodes of effusion, swelling and/or redness);
- Persistent and moderate or severe knee pain (VAS score \> 4);
- 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).
- Signature of informed consent
- Case declared eligible for treatment following discussion at internal multidisciplinary meeting on degenerative-inflammatory disease
Exclusion criteria
- Mentally incompetent patients;
- Patients with trauma in the 6 months prior to treatment;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients on anticoagulant-antiaggregant therapy (including if therapy can be discontinued 5 days earlier);
- Patients abusing alcoholic beverages, drugs, or medications;
- Patients undergoing surgery of the affected knee in the previous 12 months;
- INR \<2;
- Platelet count \<30,000;
- Renal function: GFR\<30ml/min;
- Pregnancy;
- Allergy to iodinated contrast.
- Ineligibility to perform MRI examination.
Where it is running
1 location listed.
- IRCCS Istituto Ortopedico Rizzoli - Bologna, Bologna, Italy