Angioembolization in Knee OsteoarthritisNCT07736248
Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
A study testing genicular artery embolization, Calibrated microspheres (100-300 µm) and Microcatheter in people with Angioembolization in Knee Osteoarthritis, run by Assiut University.
Trial summary
To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Angioembolization in Knee Osteoarthritis
- What is being tested?
- genicular artery embolization, Calibrated microspheres (100-300 µm) and Microcatheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2028
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of knee osteoarthritis according to the criteria of the American College of Rheumatology.
- Radiographic evidence of osteoarthritis corresponding to Kellgren-Lawrence grades I-III.
- Moderate to severe knee pain for at least 6 months. Visual Analog Scale (VAS) score ≥5.
- Failure of conservative treatment for at least 3 months including analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, lifestyle modification, or intra-articular injections.
Who cannot join
- Kellgren-Lawrence grade IV osteoarthritis.
- Previous knee arthroplasty.
- Inflammatory arthropathies such as rheumatoid arthritis, psoriatic arthritis, or gout.
- Active local or systemic infection.
- Severe peripheral arterial disease.
- Coagulation disorders.
Show all 10Show fewer
- Renal insufficiency (raised renal chemistry).
- Pregnancy.
- Known allergy to iodinated contrast media.
- Refuse to provide written informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Super Selective Angiographic Catheterization and Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.
- Conditions
- Angioembolization in Knee Osteoarthritis
- Being tested
- genicular artery embolization, Calibrated microspheres (100-300 µm), Microcatheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular artery embolizationProcedure or surgery
Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.
Calibrated microspheres (100-300 µm)Device
Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.
MicrocatheterDevice
A 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries.
| Study group | Role | What they receive |
|---|---|---|
| genicular artery embolization | Experimental | Participants with symptomatic knee osteoarthritis will undergo super-selective genicular artery embolization using calibrated microspheres. Clinical outcomes will be assessed using pain and functional scores during follow-up. Receives: Procedure: genicular artery embolization; Device: Calibrated microspheres (100-300 µm); Device: Microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in visual analog scale (VAS) pain score
pain intensity measured using the 10-cm visual analog scale (VAS). scores range from 0 to 10, with higher scores indicating greater pain. The change from baseline to 6 months after genicular artery embolization will be assessed.
Measured: Baseline and 6 months after the Procedure
Secondary outcomes (3)
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Knee pain, stiffness, and physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total WOMAC score ranges from 0 to 96, where 0 indicates no symptoms and 96 indicates the most severe symptoms. Higher scores indicate worse pain, stiffness, and functional limitation.
Measured: Baseline, 3 months, and 6 months after the procedure
Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system consists of five dimensions, each with five levels, and responses are converted into a utility index score ranging from values below 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better health-related quality of life. Assessments will be performed at baseline, 3 months, and 6 months after the procedure.
Measured: Baseline and 6 months after the procedure
Technical Success Rate of Genicular Artery Embolization
Technical success is defined as successful selective catheterization and embolization of all target genicular arteries with completion of the planned procedure.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Angioembolization in Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Awad Mohamed Ahmed, Assiut University
- Investigators
- Moustafa Hashim Mahmoud, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736248
- Sponsor's protocol ID
- angioembolization in knee OA
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crawford DC, Miller LE, Block JE. Conservative management of symptomatic knee osteoarthritis: a flawed strategy? Orthop Rev (Pavia). 2013 Feb 22;5(1):e2. doi: 10.4081/or.2013.e2. Print 2013 Feb 22.
PubMed 23705060Lyu SR, Chiang JK, Tseng CE. Medial plica in patients with knee osteoarthritis: a histomorphological study. Knee Surg Sports Traumatol Arthrosc. 2010 Jun;18(6):769-76. doi: 10.1007/s00167-009-0946-2. Epub 2009 Oct 14.
PubMed 19826785Bohnsack M, Meier F, Walter GF, Hurschler C, Schmolke S, Wirth CJ, Ruhmann O. Distribution of substance-P nerves inside the infrapatellar fat pad and the adjacent synovial tissue: a neurohistological approach to anterior knee pain syndrome. Arch Orthop Trauma Surg. 2005 Nov;125(9):592-7. doi: 10.1007/s00402-005-0796-4.
PubMed 15891922Walsh DA, Bonnet CS, Turner EL, Wilson D, Situ M, McWilliams DF. Angiogenesis in the synovium and at the osteochondral junction in osteoarthritis. Osteoarthritis Cartilage. 2007 Jul;15(7):743-51. doi: 10.1016/j.joca.2007.01.020. Epub 2007 Mar 21.
PubMed 17376709Mapp PI, Walsh DA. Mechanisms and targets of angiogenesis and nerve growth in osteoarthritis. Nat Rev Rheumatol. 2012 May 29;8(7):390-8. doi: 10.1038/nrrheum.2012.80.
PubMed 22641138Kurien T, Kerslake RW, Graven-Nielsen T, Arendt-Nielsen L, Auer DP, Edwards K, Scammell BE, Petersen KK. Chronic postoperative pain after total knee arthroplasty: The potential contributions of synovitis, pain sensitization and pain catastrophizing-An explorative study. Eur J Pain. 2022 Oct;26(9):1979-1989. doi: 10.1002/ejp.2018. Epub 2022 Aug 19.
PubMed 35959735Sideris A, Malahias MA, Birch G, Zhong H, Rotundo V, Like BJ, Otero M, Sculco PK, Kirksey M. Identification of biological risk factors for persistent postoperative pain after total knee arthroplasty. Reg Anesth Pain Med. 2022 Mar;47(3):161-166. doi: 10.1136/rapm-2021-102953. Epub 2021 Dec 17.
PubMed 34921052Marsh J, Joshi I, Somerville L, Vasarhelyi E, Lanting B. Health care costs after total knee arthroplasty for satisfied and dissatisfied patients. Can J Surg. 2022 Sep 1;65(5):E562-E566. doi: 10.1503/cjs.006721. Print 2022 Sep-Oct.
PubMed 36302132Hawker GA, Guan J, Croxford R, Coyte PC, Glazier RH, Harvey BJ, Wright JG, Williams JI, Badley EM. A prospective population-based study of the predictors of undergoing total joint arthroplasty. Arthritis Rheum. 2006 Oct;54(10):3212-20. doi: 10.1002/art.22146.
PubMed 17009255Ashraf S, Wibberley H, Mapp PI, Hill R, Wilson D, Walsh DA. Increased vascular penetration and nerve growth in the meniscus: a potential source of pain in osteoarthritis. Ann Rheum Dis. 2011 Mar;70(3):523-9. doi: 10.1136/ard.2010.137844. Epub 2010 Nov 15.
PubMed 21081524Pap T, Distler O. Linking angiogenesis to bone destruction in arthritis. Arthritis Rheum. 2005 May;52(5):1346-8. doi: 10.1002/art.21015. No abstract available.
PubMed 15880805Bonnet CS, Walsh DA. Osteoarthritis, angiogenesis and inflammation. Rheumatology (Oxford). 2005 Jan;44(1):7-16. doi: 10.1093/rheumatology/keh344. Epub 2004 Aug 3.
PubMed 15292527Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.
PubMed 23194896Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS One. 2014 Mar 4;9(3):e90633. doi: 10.1371/journal.pone.0090633. eCollection 2014.
PubMed 24595187Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
PubMed 19407734
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super Selective Angiographic Catheterization and Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07736248
- Acronym / sponsor ID
- angioembolization in knee OA
- Conditions
- Angioembolization in Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Jul 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.
To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| genicular artery embolization | Experimental | Procedure: genicular artery embolization, Device: Calibrated microspheres (100-300 µm), Device: MicrocatheterParticipants with symptomatic knee osteoarthritis will undergo super-selective genicular artery embolization using calibrated microspheres. Clinical outcomes will be assessed using pain and functional scores during follow-up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of knee osteoarthritis according to the criteria of the American College of Rheumatology.
- Radiographic evidence of osteoarthritis corresponding to Kellgren-Lawrence grades I-III.
- Moderate to severe knee pain for at least 6 months. Visual Analog Scale (VAS) score ≥5.
- Failure of conservative treatment for at least 3 months including analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, lifestyle modification, or intra-articular injections.
Key exclusion criteria (10 listed)
- Kellgren-Lawrence grade IV osteoarthritis.
- Previous knee arthroplasty.
- Inflammatory arthropathies such as rheumatoid arthritis, psoriatic arthritis, or gout.
- Active local or systemic infection.
- Severe peripheral arterial disease.
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 |
|---|---|---|
| genicular artery embolizationSuper-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis. | Procedure or surgery | genicular artery embolization |
| Calibrated microspheres (100-300 µm)Embolic microspheres used for occlusion of the targeted genicular arteries during embolization. | Device | genicular artery embolization |
| MicrocatheterA 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries. | Device | genicular artery embolization |
Primary outcome
change from baseline in visual analog scale (VAS) pain score
Time frame: Baseline and 6 months after the Procedure
pain intensity measured using the 10-cm visual analog scale (VAS). scores range from 0 to 10, with higher scores indicating greater pain. The change from baseline to 6 months after genicular artery embolization will be assessed.
3 secondary outcomes
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Time frame: Baseline, 3 months, and 6 months after the procedure
Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)
Time frame: Baseline and 6 months after the procedure
Technical Success Rate of Genicular Artery Embolization
Time frame: During the procedure
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 4 Aug 2026.
- Background: PubMed 23705060Crawford DC, Miller LE, Block JE. Conservative management of symptomatic knee osteoarthritis: a flawed strategy? Orthop Rev (Pavia). 2013 Feb 22;5(1):e2. doi: 10.4081/or.2013.e2. Print 2013 Feb 22.
- Results publication: PubMed 19826785Lyu SR, Chiang JK, Tseng CE. Medial plica in patients with knee osteoarthritis: a histomorphological study. Knee Surg Sports Traumatol Arthrosc. 2010 Jun;18(6):769-76. doi: 10.1007/s00167-009-0946-2. Epub 2009 Oct 14.
- Results publication: PubMed 15891922Bohnsack M, Meier F, Walter GF, Hurschler C, Schmolke S, Wirth CJ, Ruhmann O. Distribution of substance-P nerves inside the infrapatellar fat pad and the adjacent synovial tissue: a neurohistological approach to anterior knee pain syndrome. Arch Orthop Trauma Surg. 2005 Nov;125(9):592-7. doi: 10.1007/s00402-005-0796-4.
- Results publication: PubMed 17376709Walsh DA, Bonnet CS, Turner EL, Wilson D, Situ M, McWilliams DF. Angiogenesis in the synovium and at the osteochondral junction in osteoarthritis. Osteoarthritis Cartilage. 2007 Jul;15(7):743-51. doi: 10.1016/j.joca.2007.01.020. Epub 2007 Mar 21.
- Results publication: PubMed 22641138Mapp PI, Walsh DA. Mechanisms and targets of angiogenesis and nerve growth in osteoarthritis. Nat Rev Rheumatol. 2012 May 29;8(7):390-8. doi: 10.1038/nrrheum.2012.80.
- Results publication: PubMed 35959735Kurien T, Kerslake RW, Graven-Nielsen T, Arendt-Nielsen L, Auer DP, Edwards K, Scammell BE, Petersen KK. Chronic postoperative pain after total knee arthroplasty: The potential contributions of synovitis, pain sensitization and pain catastrophizing-An explorative study. Eur J Pain. 2022 Oct;26(9):1979-1989. doi: 10.1002/ejp.2018. Epub 2022 Aug 19.
- Results publication: PubMed 34921052Sideris A, Malahias MA, Birch G, Zhong H, Rotundo V, Like BJ, Otero M, Sculco PK, Kirksey M. Identification of biological risk factors for persistent postoperative pain after total knee arthroplasty. Reg Anesth Pain Med. 2022 Mar;47(3):161-166. doi: 10.1136/rapm-2021-102953. Epub 2021 Dec 17.
- Results publication: PubMed 36302132Marsh J, Joshi I, Somerville L, Vasarhelyi E, Lanting B. Health care costs after total knee arthroplasty for satisfied and dissatisfied patients. Can J Surg. 2022 Sep 1;65(5):E562-E566. doi: 10.1503/cjs.006721. Print 2022 Sep-Oct.
- Results publication: PubMed 17009255Hawker GA, Guan J, Croxford R, Coyte PC, Glazier RH, Harvey BJ, Wright JG, Williams JI, Badley EM. A prospective population-based study of the predictors of undergoing total joint arthroplasty. Arthritis Rheum. 2006 Oct;54(10):3212-20. doi: 10.1002/art.22146.
- Results publication: PubMed 21081524Ashraf S, Wibberley H, Mapp PI, Hill R, Wilson D, Walsh DA. Increased vascular penetration and nerve growth in the meniscus: a potential source of pain in osteoarthritis. Ann Rheum Dis. 2011 Mar;70(3):523-9. doi: 10.1136/ard.2010.137844. Epub 2010 Nov 15.
- Results publication: PubMed 15880805Pap T, Distler O. Linking angiogenesis to bone destruction in arthritis. Arthritis Rheum. 2005 May;52(5):1346-8. doi: 10.1002/art.21015. No abstract available.
- Results publication: PubMed 15292527Bonnet CS, Walsh DA. Osteoarthritis, angiogenesis and inflammation. Rheumatology (Oxford). 2005 Jan;44(1):7-16. doi: 10.1093/rheumatology/keh344. Epub 2004 Aug 3.
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.
Moustafa Hashim Mahmoud study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing genicular artery embolization, Calibrated microspheres (100-300 µm) and Microcatheter in people with Angioembolization in Knee Osteoarthritis, run by Assiut University.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Rehab Awad Mohamed (2+01011511722, RehabAwad@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in visual analog scale (VAS) pain score (time frame: Baseline and 6 months after the Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07736248, which also lists 15 linked publications.
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 4 Aug 2026.