OsteoarthitisNCT07763158
Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
A study testing embolization therapy and Conservative treatment in people with Osteoarthitis, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthitis
- What is being tested?
- embolization therapy and Conservative treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 4 Jul 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Omar A. Batouk, PHD contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdullah International Medical Research Center
Jeddah, Mecca Region, 22490
IRB Office, +9668011111, IRB@mngha.med.sa
About this study
Official title: Prospective Randomized Trial Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
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?
Read more
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.
Read the detailed description
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 Assessing pain as primary objective and function as secondary objective will be through used tools such as WOMAC score, VAS, score.
Pain and funtion variables will be collected in the following manner:
- Pre procedure
- Six weeks after the procedure - 3 months after the procedure - 6 months after the procedure
The data will be entered to Microsoft Excel and then be analyzed on Statistical Package for the Social Sciences (SPSS) version 22.
- Conditions
- Osteoarthitis
- Being tested
- embolization therapy, Conservative treatment
- Keywords
- osteoarthritis, genicular artery embolization, pain
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization therapyProcedure or surgery
Also called genicular artery embolization
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
Conservative treatmentOther
Also called conservative management for osteoarthritis
NSAIDS, physiotherapy, weight reduction programm, or Intrarticular injections for at least 3-6 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm of genicular artery embolization | Experimental | Not described Receives: Procedure: embolization therapy |
| Control arm of conservative management | Active comparator | Not described Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
To evaluate the functional status post genicular artery embolization 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 can be used for functional status evaluation also because 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.
Measured: from enrollment until 6 months after the procedure is done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start4 Jul 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Majd A. Saemaldahar, Bacheloar, Study director, King Abdullah International Medical Research CenterOmar A. Batouk, PHD, Principal investigator, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763158
- Sponsor's protocol ID
- ICT23J/003/11
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be provided through excel sheet with no MRNs for the participants however including all required datat from your side
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07763158
- Acronym / sponsor ID
- ICT23J/003/11
- Conditions
- Osteoarthitis
- Keywords
- osteoarthritis, genicular artery embolization, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 Assessing pain as primary objective and function as secondary objective will be through used tools such as WOMAC score, VAS, score.
Pain and funtion variables will be collected in the following manner:
- Pre procedure
- Six weeks after the procedure - 3 months after the procedure - 6 months after the procedure
The data will be entered to Microsoft Excel and then be analyzed on Statistical Package for the Social Sciences (SPSS) version 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm of genicular artery embolization | Experimental | Procedure: embolization therapy |
| Control arm of conservative management | Active comparator | Other: Conservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- Patients will be recruited from King Abdulaziz Medical City, National Guard Hospital, Jeddah, Saudi Arabia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embolization therapyAlso: genicular artery embolizationGAE: 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 | Procedure or surgery | Intervention Arm of genicular artery embolization |
| Conservative treatmentAlso: conservative management for osteoarthritisNSAIDS, physiotherapy, weight reduction programm, or Intrarticular injections for at least 3-6 months | Other | Control arm of conservative management |
Primary outcome
Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: from enrollment until 6 months after the procedure is done
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.
Pain evaluation post Genicular artery embolization using Visual Analogue Scale
Time frame: from enrollment until 6 months after the procedure is done
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
1 secondary outcome
Functional status post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: from enrollment until 6 months after the procedure is done
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD will be provided through excel sheet with no MRNs for the participants however including all required datat from your side
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar A. Batouk, PHD contact
Majd A. Saemaldahar, Bacheloar study director
King Abdullah International Medical Research Center
Omar A. Batouk, PHD principal investigator
King Abdullah International Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embolization therapy and Conservative treatment in people with Osteoarthitis, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Majd A. Saemaldahar, Bacheloar (+966532679581, majdsd515@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index (time frame: from enrollment until 6 months after the procedure is done). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.