CClinicalTrials.gg
Not yet recruitingNCT07736248Updated Aug 4, 2026

Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

An interventional study of genicular artery embolization and Calibrated microspheres (100-300 µm) in Angioembolization in Knee Osteoarthritis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.

02

Conditions studied

  • Angioembolization in Knee Osteoarthritis
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.

  2. Failure of conservative treatment for at least 3 months including analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, lifestyle modification, or intra-articular injections.

Exclusion criteria

Exclusion Criteria:

  1. Kellgren-Lawrence grade IV osteoarthritis.
  2. Previous knee arthroplasty.
  3. Inflammatory arthropathies such as rheumatoid arthritis, psoriatic arthritis, or gout.
  4. Active local or systemic infection.
  5. Severe peripheral arterial disease.
  6. Coagulation disorders.
  7. Renal insufficiency (raised renal chemistry).
  8. Pregnancy.
  9. Known allergy to iodinated contrast media.
  10. Refuse to provide written informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    genicular artery embolization

    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.

    Procedure: genicular artery embolization · Device: Calibrated microspheres (100-300 µm) · Device: Microcatheter

Interventions

  • Proceduregenicular artery embolization

    Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.

  • DeviceCalibrated microspheres (100-300 µm)

    Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.

  • DeviceMicrocatheter

    A 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6 months after the Procedure

Secondary outcomes

  1. 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.

    Time frame: Baseline, 3 months, and 6 months after the procedure

  2. 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.

    Time frame: Baseline and 6 months after the procedure

  3. 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.

    Time frame: During the procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

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 23705060 ↗
  • Lyu 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 19826785 ↗
  • Bohnsack 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 15891922 ↗
  • Walsh 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 17376709 ↗
  • Mapp 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 22641138 ↗
  • Kurien 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 35959735 ↗
  • Sideris 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 34921052 ↗
  • Marsh 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 36302132 ↗
  • Hawker 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 17009255 ↗
  • Ashraf 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 21081524 ↗
  • Pap 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 15880805 ↗
  • Bonnet 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 15292527 ↗
  • Berenbaum 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 23194896 ↗
  • Palazzo 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 24595187 ↗
  • Centers 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07736248
Lead sponsor
Assiut University
Responsible party
Rehab Awad Mohamed Ahmed (principal investigator, Assiut University) — Principal investigator
First posted
Jul 30, 2026
Start date
Aug 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Aug 4, 2026

Study contacts

Rehab Awad Mohamed
Contact
RehabAwad@aun.edu.eg
2+01011511722
Moustafa Hashim Mahmoud
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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