Marshall Digital Scholar

Title

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

Authors

Mohit Bhandari
P. J. Devereaux
Thomas A. Einhorn
Lehana Thabane
Emil H. Schemitsch
Kenneth J. Koval
Frede Frihagen
Rudolf W. Poolman
Kevin Tetsworth
Ernesto Guerra-Farfán
Kim Madden
Sheila Sprague
Gordon Guyatt
Ali Oliasharazi, Marshall University, Huntington, WVFollow
Franklin D. Shuler, Marshall UniversityFollow
Jonathon Salva, Marshall UniversityFollow
James Day, Marshall UniversityFollow
Tigran Garabekyan, Marshall University, Huntington, WVFollow
Felix Cheung, Marshall University, Huntington, WVFollow
Linda Morgan, Marshall UniversityFollow
Timothy Wilson-Byrne MD, Marshall UniversityFollow
Mary Beth Cordle, Marshall UinversityFollow

Document Type

Article

Publication Date

Winter 12-11-2014

Abstract

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 hiprelated 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. Trial registration number: The HEALTH trial is registered with clinicaltrials.gov (NCT00556842).

Comments

Dr. Oliashirazi is a HEALTH Investigator who contributed to this study. The article is open access via BMJ Open. Copyright © 2015 BMJ Publishing Group Ltd. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

doi:10.1136/bmjopen-2014-006263

Recommended Citation

Bhandari M, Devereaux PJ, Einhorn TA, et al. Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial. BMJ Open 2015;5:e006263. doi:10.1136/bmjopen-2014- 006263