Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

NCT07736248 | Not Yet Recruiting

• 1 other identifier: angioembolization in knee OA
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

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.

  Baseline and 6 months after the Procedure

Secondary Outcomes (3)

• Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

  Baseline, 3 months, and 6 months after the procedure

• Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)

  Baseline and 6 months after the procedure

• Technical Success Rate of Genicular Artery Embolization

  During the procedure

Study Arms (1)

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.

Other: suerselective angioembolization of genicular artery in symptomatic knee OA

Interventions

suerselective angioembolization of genicular artery in symptomatic knee OA OTHER

Common femoral artery access will be obtained using ultrasound guidance. A 4-Fr or 5-Fr vascular sheath will be inserted. 5 Fr copra catheter or 5 Fr pernst catheters with be used. Diagnostic Angiography Selective angiography of one or more of the following arteries will be performed using microcatheter : * Superior medial genicular artery. * Superior lateral genicular artery. * Inferior medial genicular artery. * Inferior lateral genicular artery. * Descending genicular artery. * Recurrent tibial artery branches. Abnormal findings suggestive of synovial inflammation include: * Hypervascular blush. * Tumor-like neovascularity. * Early venous filling. * Increased periarticular vascularity. Superselective Embolization A microcatheter (1.7-2.4 Fr) will be advanced into target vessels. Embolization will be performed using one of the following agents: * Imipenem/Cilastatin suspension. * Polyvinyl alcohol particles (100-300 μm). * Microspheres (100-300 μm).

genicular artery embolization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Renal insufficiency (raised renal chemistry).
• Pregnancy.
• Known allergy to iodinated contrast media.
• Refuse to provide written informed consent

Sponsors & Collaborators

• Assiut University: lead

Related Publications (15)

• 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.

  PMID: 23705060 BACKGROUND

• 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.

  PMID: 19826785 RESULT

• 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.

  PMID: 15891922 RESULT

• 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.

  PMID: 17376709 RESULT

• 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.

  PMID: 22641138 RESULT

• 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.

  PMID: 35959735 RESULT

• 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.

  PMID: 34921052 RESULT

• 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.

  PMID: 36302132 RESULT

• 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.

  PMID: 17009255 RESULT

• 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.

  PMID: 21081524 RESULT

• 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.

  PMID: 15880805 RESULT

• 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.

  PMID: 15292527 RESULT

• 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.

  PMID: 23194896 RESULT

• 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.

  PMID: 24595187 RESULT

• 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.

  PMID: 19407734 RESULT

Study Officials

• Moustafa Hashim Mahmoud

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Rehab Awad Mohamed

CONTACT

2+01011511722; RehabAwad@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07