Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
1. august 2026 opdateret af: Rehab Awad Mohamed Ahmed, Assiut University
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rehab Awad Mohamed
- Telefonnummer: 2+01011511722
- E-mail: RehabAwad@aun.edu.eg
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.
Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.
A 2.0-2.4
Fr microcatheter used for super-selective catheterization of the genicular arteries.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change from baseline in visual analog scale (VAS) pain score
Tidsramme: 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.
|
Baseline and 6 months after the Procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Technical Success Rate of Genicular Artery Embolization
Tidsramme: During the procedure
|
Technical success is defined as successful selective catheterization and embolization of all target genicular arteries with completion of the planned procedure.
|
During the procedure
|
|
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Tidsramme: Baseline, 3 months, and 6 months after the procedure
|
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.
|
Baseline, 3 months, and 6 months after the procedure
|
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Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)
Tidsramme: Baseline and 6 months after the procedure
|
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.
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Baseline and 6 months after the procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Moustafa Hashim Mahmoud, Assiut University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. august 2028
Studieafslutning (Anslået)
1. september 2028
Datoer for studieregistrering
Først indsendt
21. juli 2026
Først indsendt, der opfyldte QC-kriterier
25. juli 2026
Først opslået (Faktiske)
30. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- angioembolization in knee OA
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