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Randomised controlled trial comparing hydroxyapatite coated uncemented hemiarthroplasty with cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures: a protocol for the WHITE 5 study
  1. Miguel Antonio Fernandez1,2,
  2. Juul Achten1,
  3. Robin Gillmore Lerner1,
  4. Katy Mironov1,
  5. Nicholas Parsons3,
  6. Melina Dritsaki4,
  7. May E Png4,
  8. Alwin McGibbon5,
  9. Jenny Gould5,
  10. Xavier Griffin1,
  11. Matthew L Costa1
  1. 1 Oxford Trauma, NDORMS, University of Oxford, Oxford, UK
  2. 2 Trauma & Orthopaedic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
  3. 3 Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK
  4. 4 Oxford Clinical Trial Unit, NDORMS, University of Oxford, Oxford, UK
  5. 5 Patient Representative, London, UK
  1. Correspondence to Professor Matthew L Costa; matthew.costa{at}ndorms.ox.ac.uk

Abstract

Introduction Hip fracture is a serious injury in adults, especially those aged over 60 years. The most common type of hip fracture (displaced intracapsular) is treated for the majority of patients with a partial hip replacement (hemiarthroplasty). The hemiarthroplasty implant can be fixed to the bone with or without bone cement. Cement is the current recommended technique but recently some risks have been identified, which could potentially be avoided by using uncemented implants. Controversy, therefore, remains about which type of hemiarthroplasty offers patients the best outcomes.

This is the protocol for a multicentre randomised controlled trial comparing cemented hemiarthroplasty versus uncemented hemiarthroplasty for patients 60 years and over with a displaced intracapsular hip fracture.

Methods and analysis Multicentre (a minimum of seven UK hospitals), multisurgeon, parallel group, two-arm, superiority, randomised controlled trial. Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either a cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty. Otherwise all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: health-related quality of life (EuroQol 5 dimensions 5 levels) at 4 months postinjury. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. Secondary outcomes include mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12 months and health resource use. A within-trial economic analysis will be conducted.

Ethics, dissemination and funding Wales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383). This study is sponsored by the University of Oxford and funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-0215–36043 and PB-PG-1216–20021). A manuscript for a peer-reviewed journal will be prepared and the results shared with patients via local mechanisms at participating centres.

Trial registration number ISRCTN18393176

  • hip fracture
  • hemiarthroplasty
  • randomised controlled trial

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Twitter @oxfordtrauma, @xlgriffin

  • Contributors MLC, JA, NP, MAF, MD, AM, JG and XG were responsible for obtaining grant funding for this trial. MAF, MLC, JA, RGL, KM, MEP, AM, JG, NP and XG developed the trial protocol and contributed to writing the manuscript. NP developed the statistical analysis plan and is leading the statistical analysis for the study. MD and MEP developed the economic analysis plan and MEP is leading the economic analysis for the study. All authors reviewed and agreed the final manuscript.

  • Funding This project is funded by the National Institute for Health Research (NIHR), Research for Patient Benefit (PB-PG-0215-36043 and PB-PG-1216-20021) and supported by the NIHR Oxford Biomedical Research Centre.

  • Disclaimer The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care.

  • Competing interests MLC is a National Institute for Health Research (NIHR) Senior Investigator. He has ongoing expert consultancy with several companies; none involve the development of any implant for use in hip fracture care. XG is funded by a National Institute for Health Research Clinician Scientist Grant. Further funding from industry and charitable grants are and have been made available to his institution. All decisions relating to the design, conduct, analysis, write‐up and publication of research are independent of these funders. He has ongoing expert consultancy with several companies; none involve the development of any implant for use in hip fracture care.

  • Patient consent for publication Not required.

  • Ethics approval Wales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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