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Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

Bhandari, Mohit, Devereaux, P. J., Einhorn, Thomas A., Thabane, Lehana, Schemitsch, Emil H., Koval, Kenneth J., Frihagen, Frede, Poolman, Rudolf W., Tetsworth, Kevin, Guerra-Farfan, Ernesto, Madden, Kim, Sprague, Sheila, Guyatt, Gordan, Page, Richard and Health Investigators 2015, Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial, BMJ Open, vol. 5, no. 2, pp. 1-12, doi: 10.1136/bmjopen-2014-006263.

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Title Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial
Author(s) Bhandari, Mohit
Devereaux, P. J.
Einhorn, Thomas A.
Thabane, Lehana
Schemitsch, Emil H.
Koval, Kenneth J.
Frihagen, Frede
Poolman, Rudolf W.
Tetsworth, Kevin
Guerra-Farfan, Ernesto
Madden, Kim
Sprague, Sheila
Guyatt, Gordan
Page, RichardORCID iD for Page, Richard orcid.org/0000-0002-2225-7144
Health Investigators
Journal name BMJ Open
Volume number 5
Issue number 2
Article ID e006263
Start page 1
End page 12
Total pages 12
Publisher BMJ
Place of publication London, Eng.
Publication date 2015-02-13
ISSN 2044-6055
Summary Introduction Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.

Methods and analysis HEALTH is a multicentre, randomised controlled trial where 1434 patients, 50 years of age or older, with displaced femoral neck fractures from international sites are randomised to receive either THA or HA. Exclusion criteria include associated major injuries of the lower extremity, hip infection(s) and a history of frank dementia. The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes, patient quality of life, mortality and hip-related complications—both within 2 years of the initial surgery. We are using minimisation to ensure balance between intervention groups for the following factors: age, prefracture living, prefracture functional status, American Society for Anesthesiologists (ASA) Class and centre number. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial. Outcome analysis will be performed using a χ2 test (or Fisher's exact test) and Cox proportional hazards modelling estimate. All results will be presented with 95% CIs.

Ethics and dissemination
The HEALTH trial has received local and McMaster University Research Ethics Board (REB) approval (REB#: 06-151).

Results Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.
Language eng
DOI 10.1136/bmjopen-2014-006263
Field of Research 110314 Orthopaedics
111799 Public Health and Health Services not elsewhere classified
Socio Economic Objective 920116 Skeletal System and Disorders (incl. Arthritis)
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30076816

Document type: Journal Article
Collections: School of Medicine
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.