Current studentsExisting staffContact us
 

Dual-mobIlity verSus conventional total hip arthroplasty In femoral neck fractures, a registry-nested, open-label, cluster-randomized crossover trial (DISTINCT)

Simple item page
dc.contributor.authorFarey, J.E.
dc.contributor.authorAlland, T.
dc.contributor.authorNaylor, J.M.
dc.contributor.authorKelly, T.L.
dc.contributor.authorCashman, K.
dc.contributor.authorLorimer, M.
dc.contributor.authorHolder, C.
dc.contributor.authorLewin, A.M.
dc.contributor.authorGarden, F.
dc.contributor.authorLaw, C.K.
dc.contributor.authorClose, J.C.T.
dc.contributor.authorGraves, S.E.
dc.contributor.authorde Steiger, R.
dc.contributor.authorLewis, P.
dc.contributor.authorAdie, S.
dc.contributor.authorLujic, S.
dc.contributor.authorHarris, I.A.
dc.date.issued2025
dc.description.abstractAims: A statistical analysis plan for analysis of DISTINCT (Dual-mobIlity verSus conventional Total hip arthroplasty In femoral Neck fractures, a registry-nested, open-label, Cluster-randomized crossover Trial) is outlined to aid transparency in analytical procedures. Methods: DISTINCT aims to determine whether dual-mobility total hip arthroplasty (THA) is superior to conventional THA in reducing postoperative prosthetic hip dislocations in patients undergoing surgery for femoral neck fractures. The trial is nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters comprised hospitals that perform at least 12 THAs for femoral neck fracture per annum. Each hospital was randomized to two sequential periods of dual-mobility THA and conventional THA, with the order randomly allocated. Crossover occurred once sites had recruited an average of 16 patients eligible for the primary analysis in the initial allocation, to provide an average of 32 patients per cluster. The primary outcome is the incidence of prosthetic hip dislocation in the first postoperative year. Secondary outcomes are the rate of revision for dislocation, all-cause revision, mortality at one, two, and five years, and complication rates at one year. All analyses will use cluster summary methods, weighted by cluster size to account for unequal cluster sizes. Participants will be analyzed in the groups to which they were randomized (intention-to-treat). Sensitivity analyses will be performed to analyze the unadjusted primary outcome based on treatment received (as-treated) and per-protocol groupings. Conclusion: This statistical analysis plan describes the detailed analysis of the DISTINCT study, a registry-nested, open-label, cluster-randomized crossover trial that will provide supporting evidence for prosthesis choice in the common clinical problem of femoral neck fracture.
dc.identifier.citationBone & Joint Open, 2025; 6(8):866-875
dc.identifier.doi10.1302/2633-1462.68.BJO-2025-0042
dc.identifier.issn2633-1462
dc.identifier.issn2633-1462
dc.identifier.orcidKelly, T.L. [0000-0002-7691-9289]
dc.identifier.orcidLewis, P. [0000-0003-2641-3754]
dc.identifier.urihttps://hdl.handle.net/11541.2/44191
dc.language.isoen
dc.publisherBritish Editorial Society of Bone and Joint Surgery
dc.relation.fundingAustralian Orthopaedic Association Research Foundation
dc.relation.fundingWhitlam Orthopaedic Research Centre
dc.relation.fundingAvant Foundation
dc.rightsCopyright 2025 the DISTINCT Study Group (https://creativecommons.org/licenses/by-nc-nd/4.0/) Access Condition Notes: p This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited.
dc.source.urihttps://doi.org/10.1302/2633-1462.68.BJO-2025-0042
dc.subjectsurgical approach
dc.subjectdislocation
dc.subjectrevision
dc.subjectreplacement
dc.subjectrisk
dc.subjectsize
dc.subjecthemiarthroplasty
dc.subjecthead
dc.titleDual-mobIlity verSus conventional total hip arthroplasty In femoral neck fractures, a registry-nested, open-label, cluster-randomized crossover trial (DISTINCT)
dc.typeJournal article
pubs.publication-statusPublished
ror.fileinfo12306239420001831 13306239410001831 9917063330101831
ror.mmsid9917063330101831

Files

Original bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
9917063330101831.pdf
Size:
643.65 KB
Format:
Adobe Portable Document Format
Description:
Published version
Download

Collections