Abstract

Knee OA is a common cause of pain and disability, with many patients relying on chronic pain medications and/or joint injections. These options unfortunately result in short-term relief, or have associated increased morbidity, and knee replacement surgery may ultimately be performed. Researchers have postulated that synovial neovascularity develops as a result of inflammation and subsequently leads to knee pain. While previous overseas reports of success with GAE have been published, we present our final results from a prospective US multicenter clinical trial. 20 subjects with OA with pain greater than 50 mm (Visual Analog Scale 100mm) refractory to conservative therapy were enrolled in the study (clinicaltrials.gov NCT02850068). Subjects were excluded for: Kellgren Lawrence (KL) Stage 4, rheumatoid arthritis, infection, previous arthroplasty, renal insufficiency, or uncorrectable coagulopathy. GAE was performed using 75 or 100 um Embozene Microspheres (Boston Scientific, Marlborough, MA) in 20 subjects at 2 US centers. Subjects were assessed with MRI, Visual Analog (VAS) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain and disability scales, before and after the procedure. Adverse events were also recorded at all time points. Median baseline OA was KL stage III and baseline VAS was 72 mm (SD 14). Neovascularity was identified in the area of pain in all cases by arteriography (n=20) and GAE was technically successful in all subjects (n=20). GAE significantly improved pain at primary endpoint of 6 months as measured by VAS and WOMAC (n=20, baseline VAS 76 mm, mean decrease -47 mm, p<0.01; baseline WOMAC 61, mean decrease 32, p<0.01). No major adverse events were seen related to the procedure, however transient cutaneous ischemia was noted in 14/20 and 2 subjects experienced transient plantar sensory parasthesias. GAE is a technically feasible and effective technique in the short term to reduce pain secondary to knee osteoarthritis.

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