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In many patients who are not surgical candidates, existing treatment options are insufficient. Clinical evidence for a new treatment approach, genicular artery embolisation (GAE), is currently limited to single arm cohort, or small population randomised studies.\u00a0This trial will investigate the use of a permanent embolic agent for embolisation of abnormal genicular arterial vasculature\u00a0to reduce pain in patients with mild to moderate knee\u00a0osteoarthritis.\u00a0Up to 110 participants, 45 years or older, with knee pain for\u2009\u2265\u20093\u00a0months\u00a0resistant to conservative treatment will be randomised (1:1) to GAE or a sham procedure. The treatment group will receive embolisation using 100-micron Embozene\u2122 microspheres (Varian, a Siemens Healthineers Company) (investigational use for this indication in the UK), and the sham group will receive 0.9% saline in an otherwise identical procedure. Patients will be followed for 24\u00a0months. At 6\u00a0months, sham participants will be\u00a0offered crossover to GAE.\u00a0The primary endpoint is\u00a0change of 4 Knee Injury and OA Outcome Score subscales\u00a0(KOOS<jats:sub>4<\/jats:sub>) at 6\u00a0months post-randomisation. The study will also evaluate quality of life, health economics, imaging findings, and psychosocial pain outcomes. The primary manuscript\u00a0will\u00a0be\u00a0submitted\u00a0for\u00a0publication\u00a0after all participants complete 6 months of follow-up. The trial is expected to run for 3.5\u00a0years.<\/jats:p><jats:p><jats:italic> Trial Registration<\/jats:italic>: ClinicalTrials.gov, Identifier: NCT05423587.\n<\/jats:p>","DOI":"10.1007\/s00270-023-03477-z","type":"journal-article","created":{"date-parts":[[2023,6,19]],"date-time":"2023-06-19T22:01:57Z","timestamp":1687212117000},"page":"1276-1282","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Genicular Artery Embolisation in Patients with Osteoarthritis of the Knee (GENESIS 2): Protocol for a Double-Blind Randomised Sham-Controlled Trial"],"prefix":"10.1007","volume":"46","clinical-trial-number":[{"clinical-trial-number":"nct05423587","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5003-1070","authenticated-orcid":false,"given":"Mark W.","family":"Little","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Harrison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"MacGill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Archie","family":"Speirs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James H.","family":"Briggs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Tayton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nev L. 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RH has received honorarium from Crannmed. JB has received payment for delivering educational webinars from Merit Medical and is a member of the safety and quality board in the British Society of Interventional Radiology. HH, CM, LL, and RS are employees of Varian Medical Systems, a Siemens Healthineers Company, and CM, LL, and RS have stock or stock options in the company. The other authors declare that they have no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants will be in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent will be obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Consent for publication will be obtained for every individual person\u2019s data included in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}