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Could blocking tiny leg arteries relieve knee arthritis pain?

NCT ID NCT04456569

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests a procedure called geniculate artery embolization for people with mild to moderate knee osteoarthritis. The treatment blocks abnormal blood vessels in the knee to reduce pain and swelling. Twenty participants will be randomly assigned to either receive the procedure plus standard care (physical therapy and anti-inflammatory drugs) or standard care alone. The goal is to see if the procedure is safe and provides better symptom 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Aug 2027

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.

Ages

40 to 70 years

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: * Between 40 - 70 years of age. * Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude). * Symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or intra-articular injections of the affected knee in the last 3 months). * Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee * Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months. * Willing to comply with regular follow up during the 12 month follow-up period. * Not a current candidate for partial or total knee arthroplasty. * WOMAC Score \>=6 in at least 2 categories. Exclusion Criteria: * BMI \>35 kg/m2 * Advanced peripheral arterial disease (resting ABI \<= 0.9). * Known significant peripheral arterial disease precluding common femoral catheterization * Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year * Diabetics with hemoglobin A1C of \>9% * Previous lower extremity embolization * Uncontrolled emotional disorders per patient medical history * Chronic pain syndrome or currently under a pain contract. * Anatomic variants involving the lower extremities which would increase the risk of non-target embolization * Renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis. * Abnormal INR (\>1.5) * Platelet count \<50x109/L. * Currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure. * Known severe allergy to iodine which cannot be adequately pre-medicated * Pregnant or intend to become pregnant within 6 months of the procedure * Contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl * Life expectancy \<60 months * Currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial * Contraindications to medical and physical rehabilitative treatments of OA. * Advanced atherosclerosis. * Current or previous lower extremity fistula. * Rheumatoid arthritis or seronegative arthropathies. * WOMAC Pain Scale \< 6 * Steroid injection in the affected joint within 3 months of screening. I- n investigator assessment, patient is not a candidate for study participation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.