Genicular artery embolisation in patients with osteoarthritis of the knee (GENESIS 2): protocol for a double-blind randomised sham-controlled trial

Little, M. W. ORCID: https://orcid.org/0000-0002-5003-1070, Harrison, R. ORCID: https://orcid.org/0000-0003-3674-9622, MacGill, S., Speirs, A., Briggs, J. H., Tayton, E., Davies, N. L. C., Hausen, H. S., McCann, C., Levine, L. L., Sharma, R. A. and Gibson, M. (2023) Genicular artery embolisation in patients with osteoarthritis of the knee (GENESIS 2): protocol for a double-blind randomised sham-controlled trial. Cardiovascular and Interventional Radiology. ISSN 0174-1551 doi: 10.1007/s00270-023-03477-z

Abstract/Summary

Knee osteoarthritis is a leading cause of chronic disability and economic burden. 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. This trial will investigate the use of a permanent embolic agent for embolisation of abnormal genicular arterial vasculature to reduce pain in patients with mild to moderate knee osteoarthritis. Up to 110 participants, 45 years or older, with knee pain for ≥ 3 months resistant to conservative treatment will be randomised (1:1) to GAE or a sham procedure. The treatment group will receive embolisation using 100-micron Embozene™ 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 months. At 6 months, sham participants will be offered crossover to GAE. The primary endpoint is change of 4 Knee Injury and OA Outcome Score subscales (KOOS ) at 6 months post-randomisation. The study will also evaluate quality of life, health economics, imaging findings, and psychosocial pain outcomes. The primary manuscript will be submitted for publication after all participants complete 6 months of follow-up. The trial is expected to run for 3.5 years.

Item Type	Article
URI	https://reading-clone.eprints-hosting.org/id/eprint/112427
Identification Number/DOI	10.1007/s00270-023-03477-z
Refereed	Yes
Divisions	Interdisciplinary Research Centres (IDRCs) > Centre for Integrative Neuroscience and Neurodynamics (CINN)
Uncontrolled Keywords	Embolisation, Embozene™, Osteoarthritis, Embolic agent, Knee joint, Microspheres, Arteries, Interventional radiology, Arthralgia, Artery embolisation, Knee, Chronic pain
Publisher	Springer
Download/View statistics	View download statistics for this item