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Title: SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial.
Austin Authors: Anderson, David B;Ferreira, Manuela L;Harris, Ian A;Davis, Gavin A ;Stanford, Ralph;Beard, David;Li, Qiang;Jan, Stephen;Mobbs, Ralph J;Maher, Christopher G;Yong, Renata;Zammit, Tara;Latimer, Jane;Buchbinder, Rachelle
Affiliation: Insitute of Bone and Joint Research, The Kolling Institute, University of Sydney, Sydney, New South Wales, Australia
Department of Neurosurgery, Cabrini Hospital, Malvern, Victoria, Australia
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales, St Leonards, New South Wales, Australia
Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Science, NIHR Biomedical Research Unit, University of Oxford, Oxford, UK
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
Monash Department of Clinical Epidemiology, Cabrini Institute, Melbourne, Victoria, Australia
Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
School of Public Health, The University of Sydney, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Department of Orthopaedic Surgery, Prince of Wales Hospital, Randwick, New South Wales, Australia
Department of Neurosurgery, Prince of Wales Private Hospital, Randwick, New South Wales, Australia
NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia
Department of Neurosurgery, Austin Health, Heidelberg, Victoria, Australia
Issue Date: 13-Feb-2019 2019-02-13
Publication information: BMJ Open 2019; 9(2): e024944
Abstract: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial -the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. Ethics approval has been granted by the NSW Health (reference:17/247/POWH/601) and the Monash University (reference: 12371) Human Research Ethics Committees. Dissemination of results will be via journal articles and presentations at national and international conferences. ACTRN12617000884303; Pre-results.
DOI: 10.1136/bmjopen-2018-024944
PubMed URL: 30765407
Type: Journal Article
Subjects: lumbar spinal stenosis
placebo controlled trial
randomised controlled trial
Appears in Collections:Journal articles

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