"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"

NCT07140367 | Not Yet Recruiting

• 1 other identifier: CE AVEC: 350/2025/Oss/IOR
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inflammatory Articular Diseases; Knee Osteoarthristis

Keywords

embolization; transarterial microembolization; TAME; arthritis; inflammatory articular disease; arthropathy; knee; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Reduction of pain (VAS score)

  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.

  1 year

Secondary Outcomes (5)

• Improvement in quality of life (SF-36)

  2 years

• Pain, stiffness, and physical functioning of the joints (WOMAC score)

  2 years

• Range of motion

  2 years

• Overall assessment of treatment

  2 years

• Bilateral Trans- and Suprapatellar Circumferences

  2 years

Study Arms (1)

Performed microembolization

Procedure: Transarterial Microembolization

Interventions

Transarterial Microembolization PROCEDURE

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).

Also known as: TAME, embolization, transarterial embolization

Performed microembolization

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by inflammatory arthropathy of the knee who underwent genicular artery microembolization.

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

Location

Related Publications (3)

• Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.

  PMID: 38102013 BACKGROUND

• Little MW, O'Grady A, Briggs J, Gibson M, Speirs A, Al-Rekabi A, Yoong P, Ariyanayagam T, Davies N, Tayton E, Tavares S, MacGill S, McLaren C, Harrison R. Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results. Cardiovasc Intervent Radiol. 2024 Dec;47(12):1750-1762. doi: 10.1007/s00270-024-03752-7. Epub 2024 May 31.

  PMID: 38819473 BACKGROUND

• Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015 Apr;38(2):336-43. doi: 10.1007/s00270-014-0944-8. Epub 2014 Jul 4.

  PMID: 24993956 BACKGROUND

MeSH Terms

Conditions

Arthritis; Joint Diseases; Osteoarthritis

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Central Study Contacts

Giancarlo Facchini, Medicine and Surgery

CONTACT

+39 0516366836; giancarlo.facchini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)