Status:
NOT_YET_RECRUITING
"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Inflammatory Articular Diseases
Knee Osteoarthristis
Eligibility:
All Genders
40+ years
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 treat...
Detailed Description
Degenerative and inflammatory joint disease is a common and debilitating condition that causes pain and limited mobility, with osteoarthritis (OA) being the most common form. The knee is the most comm...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT07140367
Start Date
September 1 2025
End Date
September 1 2031
Last Update
August 24 2025
Active Locations (1)
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1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy, 40136