Abstract | INTRODUCTION: 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 χ(2) 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).
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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, HEALTH Investigators |
Journal | BMJ open
(BMJ Open)
Vol. 5
Issue 2
Pg. e006263
(Feb 13 2015)
ISSN: 2044-6055 [Electronic] England |
PMID | 25681312
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. |
Topics |
- Aged
- Aged, 80 and over
- Arthroplasty, Replacement, Hip
(methods)
- Clinical Protocols
- Female
- Femoral Neck Fractures
(surgery)
- Hemiarthroplasty
(methods)
- Hip
(surgery)
- Hip Fractures
(surgery)
- Humans
- Male
- Middle Aged
- Quality of Life
- Research Design
- Treatment Outcome
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