Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE
Susan Ball,
Amy McAndrew,
Alex Aylward,
Emma Cockcroft,
Elizabeth Gordon,
Alison Kerridge,
Sarah Morgan-Trimmer,
Roy Powell,
Anna Price,
Shelley Rhodes,
Andrew J. Timperley,
Jayden van Horik,
Robert Wickins,
John Charity
Affiliations
Susan Ball
Applied Research Collaboration South West Peninsula (PenARC), National Institute for Health and Care Research (NIHR), University of Exeter
Amy McAndrew
Exeter Clinical Trials Unit, University of Exeter Medical School
Alex Aylward
Applied Research Collaboration South West Peninsula (PenARC) Patient Engagement Group, National Institute for Health and Care Research (NIHR), University of Exeter
Emma Cockcroft
Primary Care Research Group, University of Exeter Medical School
Elizabeth Gordon
Research and Development Department, Royal Devon University Healthcare NHS Foundation Trust
Alison Kerridge
Research and Development Department, Royal Devon University Healthcare NHS Foundation Trust
Sarah Morgan-Trimmer
Department of Health and Community Sciences, University of Exeter Medical School
Roy Powell
Research Design Service – South West, Royal Devon University Healthcare NHS Foundation Trust
Anna Price
Primary Care Research Group, University of Exeter Medical School
Shelley Rhodes
Exeter Clinical Trials Unit, University of Exeter Medical School
Andrew J. Timperley
Exeter Hip Unit, Royal Devon University Healthcare NHS Foundation Trust
Jayden van Horik
Exeter Clinical Trials Unit, University of Exeter Medical School
Robert Wickins
Physiotherapy, Royal Devon University Healthcare NHS Foundation Trust
John Charity
Exeter Hip Unit, Royal Devon University Healthcare NHS Foundation Trust
Abstract Background The HemiSPAIRE trial is being conducted to determine whether a modified muscle sparing technique (SPAIRE-“Save Piriformis and Internus, Repairing Externus”) in hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in adults aged 60 years or older, with a displaced intracapsular hip fracture. This article describes the detailed statistical analysis plan for the trial. Methods and design HemiSPAIRE is a definitive, pragmatic, superiority, multicentre, randomised controlled trial (with internal pilot) with two parallel groups. Participants, ward staff and all research staff involved in post-operative assessments are blinded to allocation. This article describes in detail (1) the primary and secondary outcomes; (2) the statistical analysis principles, including a survivor average causal effect (SACE) method chosen specifically to address the issue of potential bias from differential survival between trial arms, which was seen from data review by the Trial Steering Committee, the participants that will be included in each analysis, the covariates that will be included in each analysis, and how the results will be presented; (3) planned main analysis of the primary outcome; (4) planned analyses of the secondary outcomes; and (5) planned additional analyses of the primary and secondary outcomes. Trial registration ClinicalTrials.gov NCT04095611. Registered on 19 September 2019.
