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

NCT07763158 | Recruiting DMC

• 1 other identifier: ICT23J/003/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

osteoarthritis; genicular artery embolization; pain

Outcome Measures

Primary Outcomes (2)

• Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index

  To evaluate the role of genicular artery embolization in treatment of persistent pain using Western Ontario and McMaster Universities Osteoarthritis Index in patients with severe knee osteoarthritis. For the Western Ontario and McMaster Universities Osteoarthritis Index score it includes 3 parameters which are pain, stiffness, and physical function and scored from 0 to 4 having 0 as None and 4 as the most extreme for each variable, and for the total score having 0 is the best response and 96 is the worst.

  from enrollment until 6 months after the procedure is done

• Pain evaluation post Genicular artery embolization using Visual Analogue Scale

  To evaluate the role of genicular artery embolization in treatment of persistent pain using Visual Analogue Scale in patients with severe knee osteoarthritis. For Visual Analogue Scale score it is used to assess the pain only from 0 to 10 having 0 is None and 10 is the most Extreme

  from enrollment until 6 months after the procedure is done

Secondary Outcomes (1)

• Functional status post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index

  from enrollment until 6 months after the procedure is done

Study Arms (2)

Intervention Arm of genicular artery embolization

EXPERIMENTAL

Procedure: embolization therapy

Control arm of conservative management

ACTIVE COMPARATOR

Other: Conservative treatment

Interventions

embolization therapy PROCEDURE

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

Also known as: genicular artery embolization

Intervention Arm of genicular artery embolization

Conservative treatment OTHER

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

Also known as: conservative management for osteoarthritis

Control arm of conservative management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older of either sex. Diagnosis of knee osteoarthritis with a Kellgren-Lawrence grade of 3 or higher. Persistent knee pain resistant to conservative treatment for at least 3 months. Conservative treatment includes NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections.
• Patients with multiple comorbidities who are indicated for operative treatment, such as total knee arthroplasty, for pain management but are unable to undergo surgery due to their medical status.

You may not qualify if:

• Previous knee arthroplasty in the affected knee. Known malignancy. Local infection. Rheumatoid arthritis. Intra-articular injection in the affected knee within the previous 6 months. Body weight greater than 150 kg. Renal impairment. Irreversible coagulopathy. Peripheral vascular disease.
• Study Population:
• Patients will be recruited from King Abdulaziz Medical City, National Guard Hospital, Jeddah, Saudi Arabia.

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

King Abdullah International Medical Research Center

Jeddah, Mecca Region, 22490, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Embolization, Therapeutic; Conservative Treatment

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Majd A. Saemaldahar, Bacheloar

  King Abdullah International Medical Research Center

  STUDY DIRECTOR

• Omar A. Batouk, PHD

  King Abdullah International Medical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Majd A. Saemaldahar, Bacheloar

CONTACT

+966532679581; majdsd515@gmail.com

Omar A. Batouk, PHD

CONTACT

batoukoa@mngha.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial were subjects will be chosen through envelop opaque technique, and all subjects will be included according to inclusion and exclusion criteria The intervention of interest is genicular artery embolization and our main outome is assessing pain post procedure The control group will be patients on conservative therapy such as (NSAIDS, physiotherapy, weight reduction programm, Intrarticular injections) This control group will be compared to the other two limbs of the study which are patinet who undergo embolization

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 13, 2026
• Study Start: July 4, 2024
• Primary Completion: October 1, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: October 2024-September 2027
• Access Criteria: Individual participant data may be shared with qualified researchers upon reasonable request for legitimate scientific research purposes. Requests must include a brief research proposal describing the intended analysis and objectives. Requests will be reviewed by the study investigators to ensure that the proposed use is scientifically sound, consistent with the informed consent provided by participants, and complies with applicable ethical and data privacy requirements. Approved data requests will require a data-sharing agreement, and only de-identified data will be provided. Data will be shared following approval of the request and completion of the required data-sharing agreement.

Locations

SA (1)