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New embolization technique could offer knee pain relief without surgery

NCT ID NCT07140367

Symptom relief Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a procedure called transarterial microembolization (TAME) for people with knee osteoarthritis and long-lasting pain that hasn't improved with standard treatments. Doctors will inject tiny beads into blood vessels around the knee to block abnormal blood flow, aiming to reduce pain and improve quality of life. Forty-three participants will be followed for up to two years to see if the procedure works and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transarterial microembolization (TAME) procedure using Nexsphere-F embolic beads
What this could lead to
If it works, this could offer a new, less invasive option to ease chronic knee pain and delay or avoid knee replacement surgery.
What could go wrong
This is a small, early observational study with only 43 participants and no comparison group, so results may not apply broadly. The procedure carries risks like bleeding, infection, or incomplete pain relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 43 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

arthritic joint disease arthropathy osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory articular diseases Knee osteoarthristis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, Bologna, 40136, Italy

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