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dc.contributor.authorBall, S.
dc.contributor.authorMcAndrew, A.
dc.contributor.authorAylward, A.
dc.contributor.authorCockcroft, E.
dc.contributor.authorGordon, E.
dc.contributor.authorKerridge, A.
dc.contributor.authorMorgan-Trimmer, S.
dc.contributor.authorPowell, R.
dc.contributor.authorPrice, A.
dc.contributor.authorRhodes, S.
dc.contributor.authorTimperley, A. J.
dc.contributor.authorvan Horik, J.
dc.contributor.authorWickins, R.
dc.contributor.authorCharity, J.
dc.identifier.citationTrials. 2022 Nov 5;23(1):924. doi: 10.1186/s13063-022-06790-z.
dc.description.abstractBACKGROUND: 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: NCT04095611. Registered on 19 September 2019."
dc.publisherBioMed Central
dc.rights© 2022. The Author(s).
dc.subject*Hemiarthroplasty/adverse effects/methods
dc.subject*Hip Fractures/surgery
dc.subject*Arthroplasty, Replacement, Hip/methods
dc.subjectTreatment Outcome
dc.subjectHip hemiarthroplasty
dc.subjectRandomised controlled trial
dc.subjectStatistical analysis plan
dc.subjectSurvivor average causal effect
dc.titleDetailed 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
dc.typeRandomized Controlled Trial
dc.description.noteThe article is available via Open Access. Click on the 'Additional link' above to access the full-text.
dc.description.admin-notePublished version

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© 2022. The Author(s).
Except where otherwise noted, this item's license is described as © 2022. The Author(s).