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Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis

NCT07763158 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-13

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to evaluate the role of genicular artery embolization (GAE) in treating persistent pain in patients with severe knee osteoarthritis who have failed conservative treatment and may be unable to undergo surgical treatment because of significant medical commodities. The main questions it aims to answer are:

Does genicular artery embolization reduce persistent knee pain in patients with severe knee osteoarthritis?

Researchers will compare patients who undergo genicular artery embolization with patients who continue conservative treatment, including NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections, to evaluate differences in pain.

Participants will:

* Undergo assessment of knee pain and function using the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score before treatment.
* Be randomly assigned to either genicular artery embolization or continued conservative treatment.
* Have pain and functional outcomes assessed before treatment and at 6 weeks, 3 months, and 6 months after the intervention.

Conditions

  • Osteoarthitis

Interventions

PROCEDURE

embolization therapy

GAE: Genicular artery embolization GAE To be performed under local anesthesia \- Immediately prior to the procedure, the focal areas of pain identified by the patient should be marked with a radiopaque marker.. Access to the ipsilateral common femoral artery is performed with a 21-gauge needle, with exchange to a 3-French vascular sheath which is replaced by 5 French one 11 cm length by using a metallic guide wire. * 4Fr. 65-cm-angled Glidecath to be advanced into the mid-to-distal portion of the superficial femoral artery, proximal to the descending genicular artery origin. * The selection of which artery to embolize is based on the angiographic evidence of hyperemia at the cartilage level Embolization is performed with 100-300mm Embozene particles. Embolization is performed until distal hypervascularity resolved, yet normal arterial flows is preserved within the selected artery. * After embolization, a completion femoral artery angiogram should be performed. Compression for 5 minute

OTHER

Conservative treatment

NSAIDS, physiotherapy, weight reduction programm, or Intrarticular injections for at least 3-6 months

Sponsors & Collaborators

  • King Abdullah International Medical Research Center

    lead OTHER

Principal Investigators

  • Majd A. Saemaldahar, Bacheloar · King Abdullah International Medical Research Center

  • Omar A. Batouk, PHD · King Abdullah International Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-04
Primary Completion
2026-10-01
Completion
2027-09-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07763158 on ClinicalTrials.gov