"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"

NCT ID: NCT07140367

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2031-09-01

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.

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 commonly affected joint, with an estimated 600 million people worldwide currently living with unilateral or bilateral knee OA, marking a 113% increase since 1990. Although risk factors include obesity, advanced age, and female gender, most individuals are susceptible to the pathophysiological cascade of OA, which likely explains the dramatic global burden of the disease and its associated economic consequences. These joint disorders have a significant impact on individuals' quality of life. When they occur in mild or moderate form, a series of therapeutic strategies can be implemented, but these rarely lead to a significant reduction in pain and do not alter the course of the disease. Standard treatment includes exercise, postural measures, weight control, and pharmacotherapy. Intra-articular injections of hyaluronic acid or platelet-rich plasma (PRP) have emerged as new non-surgical treatment options. Surgical joint replacement is reserved for the most severe cases, with intense pain and functional disability. However, many patients suffer from refractory chronic pain, are not candidates for surgery, or refuse it. In addition, some patients may experience complications associated with long-term pharmacotherapy, such as renal or hepatic failure, opioid dependence, or local problems resulting from injections, such as infections. In recent years, geniculate artery embolization has emerged as a promising option for patients with knee pain due to OA who are refractory to conservative therapies and who are not eligible for or choose not to undergo arthroplasty surgery.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Performed microembolization

Transarterial Microembolization

Intervention Type: 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).

Interventions

Transarterial Microembolization

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).

Intervention Type: PROCEDURE

Other Intervention Names

TAME; embolization; transarterial embolization

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Giancarlo Facchini

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy

Countries

Italy

Central Contacts

Giancarlo Facchini, Medicine and Surgery

Role: CONTACT

giancarlo.facchini@ior.it

+39 0516366836

References

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.

Reference Type: BACKGROUND

PMID: 38102013 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38819473 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24993956 (View on PubMed)

Other Identifiers

CE AVEC: 350/2025/Oss/IOR

Identifier Type: -

Identifier Source: org_study_id