Not yet recruiting NCT07736248
Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: genicular artery embolization, Calibrated microspheres (100-300 µm), Microcatheter.
- Who it may be relevant to
- Registry conditions: Angioembolization in Knee Osteoarthritis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Super Selective Angiographic Catheterization and Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
Overview
To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.
Interventions
- Procedure genicular artery embolization
Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis. - Device Calibrated microspheres (100-300 µm)
Embolic microspheres used for occlusion of the targeted genicular arteries during embolization. - Device Microcatheter
A 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries.
Primary outcome measures
- change from baseline in visual analog scale (VAS) pain score [Time frame: Baseline and 6 months after the Procedure]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 36302132
Identifiers
NCT: NCT07736248 · angioembolization in knee OA