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Micro-embolisation to improve pain & function in early stage knee osteoarthritis 24 month pilot study results Steve Landers 1 , Rachael Hely 1 , Richard Page 2,3 , Andrew Hely 1 . Benjamin Harrison 1 , Nicholas Maister 1 , Stephen Gill 1,2,3 1 Barwon Medical Imaging, Barwon Health; 2 Barwon Centre for Orthopaedic Research & Education (B-CORE); 3 Deakin University, School of Medicine BACKGROUND Symptomatic knee osteoarthritis (OA) is a common and disabling disease. OA has no known cure and treatment is directed towards modifying symptoms. In late stage OA, symptoms can be successfully treated with arthroplasty, but early stage OA management can be challenging. OA is accompanied by angiogenesis, which is blood vessel outgrowth from pre-existing vasculature (Figure 1A). Blocking the flow of blood in these neovessels via micro- embolization is an emerging treatment option for OA. One single- arm study has previously demonstrated large improvements in pain and function in participants following micro-embolisation. AIMS 1. Investigate the safety and feasibility of micro-embolisation in people with mild knee OA 2. Investigate effects of micro-embolisation on pain, function and quality of life at 1, 6, 12 & 24 months METHODS Study Design: single-arm prospective pilot study Study site: Barwon Health Participants: 10 people with symptomatic early stage knee OA who had failed traditional conservative management Intervention: transcatheter arterial embolisation in the angiography suite at Barwon Medical Imaging (see Image). A microcatheter was inserted into the femoral artery at the groin and passed to the knee. Iodinated contrast agent was inserted to reveal neovasculature on angiogram. Embolic particles were inserted to block neovessels and return vasculature to its normal state. The procedure took 60- 120minutes. Participants were discharged home after 4 hours of observation. Primary outcome: proportion of ‘responders’ at 12 months. A responder fulfils at least two criteria: 1. Pain improved >20% from baseline and absolute change >10 points on a 0-100 interval scale 2. Function improved >20% from baseline and absolute change >10 points on a 0-100 interval scale 3. Patient’s global assessment of ‘moderately better’ or ‘much better’ 0 1 2 3 4 5 6 7 8 1 month 6 month 12 months 24 months Number of participants Global Change - participant reported worse no change improved 0% 10% 20% 30% 40% 50% 60% 70% 80% 1 month 6 months 12 months 24 months % Responders Responders to intervention RESULTS Technical success: neovessels were identified and embolised in all participants Safety: no adverse events occurred. No osteonecrosis (bone death) was observed on 24 month MRI. Follow up: 10 participants to 12 months; 8 participants to 24 months CONCLUSIONS Post-procedural improvements provide evidence that micro-embolisation might be an effective symptomatic treatment technique for people with early stage knee osteoarthritis. Evaluating the procedure with more advanced study designs is warranted to produce higher quality evidence regarding this novel procedure; a randomised, placebo-controlled, assessor and participant blinded study is now underway (a world-first). Angiography suite 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% 1 month 6 months 12 months 24 months % Improvement (from baseline) Physical Performance Chair stand test Six minute walk test

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Page 1: Micro-embolisation to improve pain & function in early ...€¦ · Micro-embolisation to improve pain & function in early stage knee osteoarthritis 24 month pilot study results Steve

Micro-embolisation to improve pain & function in early stage knee osteoarthritis24 month pilot study results

Steve Landers1, Rachael Hely1, Richard Page2,3, Andrew Hely1. Benjamin Harrison1, Nicholas Maister1, Stephen Gill1,2,3

1Barwon Medical Imaging, Barwon Health; 2Barwon Centre for Orthopaedic Research & Education (B-CORE); 3Deakin University, School of Medicine

BACKGROUNDSymptomatic knee osteoarthritis (OA) is a common and disablingdisease. OA has no known cure and treatment is directed towardsmodifying symptoms. In late stage OA, symptoms can be successfullytreated with arthroplasty, but early stage OA management can bechallenging.

OA is accompanied by angiogenesis, which is blood vessel outgrowthfrom pre-existing vasculature (Figure 1A).

Blocking the flow of blood in these neovessels via micro-embolization is an emerging treatment option for OA. One single-arm study has previously demonstrated large improvements in painand function in participants following micro-embolisation.

AIMS1. Investigate the safety and feasibility of micro-embolisation in

people with mild knee OA2. Investigate effects of micro-embolisation on pain, function and

quality of life at 1, 6, 12 & 24 months

METHODSStudy Design: single-arm prospective pilot studyStudy site: Barwon HealthParticipants: 10 people with symptomatic early stage knee OA whohad failed traditional conservative managementIntervention: transcatheter arterial embolisation in the angiographysuite at Barwon Medical Imaging (see Image). A microcatheter wasinserted into the femoral artery at the groin and passed to the knee.Iodinated contrast agent was inserted to reveal neovasculature onangiogram. Embolic particles were inserted to block neovessels andreturn vasculature to its normal state. The procedure took 60-120minutes. Participants were discharged home after 4 hours ofobservation.Primary outcome: proportion of ‘responders’ at 12 months. Aresponder fulfils at least two criteria:1. Pain improved >20% from baseline and absolute change >10 points

on a 0-100 interval scale2. Function improved >20% from baseline and absolute change >10

points on a 0-100 interval scale3. Patient’s global assessment of ‘moderately better’ or ‘much better’

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RESULTSTechnical success: neovessels were identified and embolised in all participantsSafety: no adverse events occurred. No osteonecrosis (bone death) was observed on 24 month MRI.Follow up: 10 participants to 12 months; 8 participants to 24 months

CONCLUSIONSPost-procedural improvements provide evidence that micro-embolisation might be an effective symptomatictreatment technique for people with early stage knee osteoarthritis. Evaluating the procedure with moreadvanced study designs is warranted to produce higher quality evidence regarding this novel procedure; arandomised, placebo-controlled, assessor and participant blinded study is now underway (a world-first).

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Physical Performance

Chair stand testSix minute walk test