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Protocol for a single-centre, parallel-arm, randomised controlled superiority trial evaluating the effects of transcatheter arterial embolisation of abnormal knee neovasculature on pain, function and quality of life in people with knee osteoarthritis

Landers, Steve, Hely, Andrew, Harrison, Benjamin, Maister, Nick, Hely, Rachael, Lane, Stephen E., Gill, Stephen D. and Page, Richard 2017, Protocol for a single-centre, parallel-arm, randomised controlled superiority trial evaluating the effects of transcatheter arterial embolisation of abnormal knee neovasculature on pain, function and quality of life in people with knee osteoarthritis, BMJ open, vol. 7, pp. 1-6, doi: 10.1136/bmjopen-2016-014266.

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Title Protocol for a single-centre, parallel-arm, randomised controlled superiority trial evaluating the effects of transcatheter arterial embolisation of abnormal knee neovasculature on pain, function and quality of life in people with knee osteoarthritis
Author(s) Landers, Steve
Hely, Andrew
Harrison, Benjamin
Maister, Nick
Hely, Rachael
Lane, Stephen E.
Gill, Stephen D.ORCID iD for Gill, Stephen D. orcid.org/0000-0001-8722-0572
Page, RichardORCID iD for Page, Richard orcid.org/0000-0002-2225-7144
Journal name BMJ open
Volume number 7
Article ID e014266
Start page 1
End page 6
Total pages 6
Publisher BMJ Publishing Group
Publication date 2017-05
ISSN 2044-6055
Keyword(s) Knee osteoarthritis
interventional radiology
knee pain
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
OUTCOME SCORE KOOS
OSTEOCHONDRAL JUNCTION
REPLACEMENT SURGERY
HIP OSTEOARTHRITIS
ANGIOGENESIS
INJURY
BURDEN
MODEL
Summary Introduction Symptomatic knee osteoarthritis (OA) is common. Advanced knee OA is successfully treated with joint replacement surgery, but effectively managing mild to moderate knee OA can be difficult. Angiogenesis increases with OA and might contribute to pain and structural damage. Modifying angiogenesis is a potential treatment pathway for OA. The aim of the current study is to determine whether transcatheter arterial embolisation of abnormal neovasculature arising from the genicular arterial branches improves knee pain, physical function and quality of life in people with mild to moderate symptomatic knee OA.

Methods and analysis
The study is a single centre, parallel-arm, double-blinded (participant and assessor), randomised controlled superiority trial with 1:1 random block allocation. Eligible participants have mild to moderate symptomatic knee OA and will be randomly assigned to receive either embolisation of aberrant knee neovasculature of genicular arterial branches or a placebo intervention. Outcome measures will be collected prior to the intervention and again 1, 6 and 12 months postintervention. The primary outcome is change in knee pain between baseline and 12 month assessment as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include change in self-reported physical function (KOOS), self-reported quality of life (KOOS, EuroQol: EQ-5D-5L), self-reported knee joint stiffness (KOOS), self-reported global change, 6 min walk test performance, and 30 s chair-stand test performance. Intention-to-treat analysis will be performed including all participants as randomised. To detect a mean between group difference in change pain of 20% at the one year reassessment with a two-sided significance level of α=0.05 and power of 80% using a two-sample t-test, we require 29 participants per arm which allows for 20% of participants to drop out.

Ethics and dissemination Barwon Health Human Research Ethics Committee, 30 May 2016, (ref:15/101). Study results will be disseminated via peer-reviewed publications and conference presentations.
Language eng
DOI 10.1136/bmjopen-2016-014266
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2017, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30097009

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.