Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial
نویسندگان
- 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
- Rob Korley
- Richard Buckley
- Paul Duffy
- Shannon Puloski
- Kimberly Carcary
- Melissa Lorenzo
- Georgia Carstensen
- Ross McKercher
- Kelly Johnston
- Greg Abelseth
- Raul Kuchinad
- Saboura Mahdavi
- Emil H Schemitsch
- Michael D McKee
- Jeremy A Hall
- Aaron Nauth
- Daniel Whelan
- Timothy R Daniels
- Earl R Bogoch
- James P Waddell
- Henry Ahn
- Milena R Vicente
- Jennifer T Hidy
- Melanie T MacNevin
- Hans Kreder
- Terry Axelrod
- Richard Jenkinson
- Markku Nousiainen
- David Stephen
- Veronica Wadey
- Monica Kunz
- Katrine Milner
- Ria Cagaanan
- Melanie MacNevin
- Peter J O'Brien
- Piotr A Blachut
- Henry M Broekhuyse
- Pierre Guy
- Kelly A Lefaivre
- Gerard P Slobogean
- Raman Johal
- Irene Leung
- Chad Coles
- Ross Leighton
- C Glen Richardson
- Michael Biddulph
- Michael Gross
- Michael Dunbar
- J David Amirault
- David Alexander
- Catherine Coady
- Mark Glazebrook
- David Johnston
- William Oxner
- Gerald Reardon
- Ivan Wong
- Kelly Trask
- Shelley MacDonald
- Andrew Furey
- Craig Stone
- Minnie Parsons
- Trevor Stone
- Mauri Zomar
- Robert McCormack
- Kelly Apostle
- Dory Boyer
- Farhad Moola
- Bertrand Perey
- Darius Viskontas
- Karyn Moon
- Raely Moon
- Yves Laflamme
- Benoit Benoit
- Pierre Ranger
- Michel Malo
- Julio Fernandes
- Karine Tardif
- Julie Fournier
- Pascal André Vendittoli
- Vincent Massé
- Alain G Roy
- Martin Lavigne
- Daniel Lusignan
- Craig Davis
- Philip Stull
- Stewart Weinerman
- Peter Weingarten
- Steven Lindenbaum
- Michael Hewitt
- Rebecca Danielwicz
- Janell Baker
- Michael Mont
- Donald E Delanois
- Bhaveen Kapadia
- Kimona Issa
- Marylou Mullen
- Andrew Sems
- Barb Foreman
- Javad Parvizi
- Tiffany Morrison
- Courtland Lewis
- Stephanie Caminiti
- Thomas A Einhorn
- Paul Tornetta
- William R Creevy
- Heather Silva
- Michelle J Lespasio
- Hope Carlisle
- Andrew Marcantonio
- Michael Kain
- Lawrence Specht
- John Tilzey
- John Garfi
- Samir Mehta
- John L Esterhai
- Jaimo Ahn
- Derek Donegan
- Annamarie Horan
- Kelly McGinnis
- James Roberson
- Thomas Bradbury
- Greg Erens
- Kyle Webb
- Brian Mullis
- Karl Shively
- Andrew Parr
- Janos Ertl
- Ripley Worman
- Mark Webster
- Judd Cummings
- Valda Frizzell
- Molly Moore
- Clifford B Jones
- James R Ringler
- Debra L Sietsema
- Jane E Walker
- Enes Kanlic
- Amr Abdelgawad
- Juan Shunia
- Charles DePaolo
- Susan Sutherland
- Rachel Alosky
- Robert Zura
- Maria Manson
- Gregg Strathy
- Kathleen Peter
- Paul Johnson
- Meaghan Morton
- James Shaer
- Tyson Schrickel
- Barbara Hileman
- Marina Hanes
- Elisha Chance
- E Matthew Heinrich
- David Dodgin
- Michele LaBadie
- David Zamorano
- Martin Tynan
- Ran Schwarzkopf
- John A Scolaro
- Ranjan Gupta
- Samuel Bederman
- Nitin Bhatia
- Bang Hoang
- Douglas Kiester
- Neil Jones
- Gregory Rafijah
- Damon Alavekios
- Jason Lee
- Akshay Mehta
- Steven Schroder
- Tom Chao
- Vincent Colin
- Phuc (Phil) Dang
- Stephen Keun Heng
- Gregory Lopez
- Samuel Galle
- Sohrab Pahlavan
- Duy L Phan
- Minal Tapadia
- Christopher Bui
- Nickul Jain
- Tyler Moore
- Nathan Moroski
- Deeba Pourmand
- Franklin D Shuler
- James Day
- Tigran Garabekyan
- Felix Cheung
- Ali Oliashirazi
- Jonathon Salava
- Linda Morgan
- Timothy Wilson-Byrne
- Mary Beth Cordle
- Carlos A Sagebien
- David A Harwood
- Stephen Kayiaros
- Patricia Seuffert
- Sridhar Rachala
- Mark Anders
- Christopher Mutty
- Matthew Philips
- Allison Cornwall
- Mary Bayers-Thering
- Michael Dohm
- Cindy Fastje
- Leon HGJ Elmans
- Joost AAM van den Hout
- Adrianus JP Joosten
- Ad FA van Beurden
- Stefan BT Bolder
- Denise Eygendaal
- Adrianus FCM Moonen
- Rutger CI van Geenen
- Eric A Hoebink
- Robert Wagenmakers
- Wouter van Helden
- Hans-Peter W van Jonbergen
- Herbert Roerdink
- Joost M Reuver
- Alexander FW Barnaart
- Elvira R Flikweert
- Rover Krips
- J Bernard Mullers
- Hans Schüller
- Mark LM Falke
- Frans J Kurek
- Adrianus CH Slingerland
- Jan P van Dijk
- Wouter H van Helden
- Hugo W Bolhuis
- Pieter HJ Bullens
- Mike Hogervorst
- Karin E de Kroon
- Rob H Jansen
- Ferry Steenstra
- Eric EJ Raven
- W Peter J Fontijne
- Saskia C Wiersma
- Bastiaan Boetes
- Edgar JT ten Holder
- Huub JL van der Heide
- Jochem Nagels
- Enrike HMJ van der Linden-van der Zwaag
- Stefan B Keizer
- Jan-Willem A Swen
- Peter HC den Hollander
- Bregje JW Thomassen
- Rudolf W Poolman
- Willem Jan Kleyn Molekamp
- Frank RAJ de Meulemeester
- Arthur EB Kleipool
- Robert Haverlag
- Maarten P Simons
- Eduard LAR Mutsaerts
- Rob Kooijman
- Roelf R Postema
- René JTM Bleker
- Harald IH Lampe
- Lein Schuman
- John Cheung
- Frank van Bommel
- W Paul CA Winia
- Daniel Haverkamp
- Harm van der Vis
- Peter A Nolte
- Michel PJ van den Bekerom
- Tjitte de Jong
- Arthur van Noort
- Diederik A Vergroesen
- Bernard G Schutte
- Harm M van der Vis
- Lijkele Beimers
- Jasper de Vries
- Arthur W Zurcher
- GH Rob Albers
- Maarten Rademakers
- Stefan Breugem
- Ibo van der Haven
- Pieter Jan Damen
- Gythe H Bulstra
- Martin M Campo
- Mathijs P Somford
- Daniël Haverkamp
- Susan Liew
- Harvinder Bedi
- Ashley Carr
- Andrew Chia
- Steve Csongvay
- Craig Donohue
- Stephen Doig
- Elton Edwards
- Max Esser
- Richard Freeman
- Andrew Gong
- Doug Li
- Russell Miller
- Lu Ton
- Otis Wang
- Ian Young
- Adam Dowrick
- Zoe Murdoch
- Claire Sage
- Frede Frihagen
- Lars Nordsletten
- John Clarke-Jenssen
- Geir Hjorthaug
- Anne Christine Brekke
- Elise Berg Vesterhus
- Ingunn Skaugrud
- Enrique Guerado
- Encarnacion Cruz
- Juan Ramon Cano
- Miguel Angel Froufe
- Lluis Marull Serra
- Samer Al-dirra
- Cristina Martinez
- Richard Page
- David Bainbridge
- Richard Angliss
- Ben Miller
- Andrew Thomson
- Graeme Brown
- Simon Williams
- Kevin Eng
- David Bowyer
- John Skelley
- Chatar Goyal
- Sally Beattie
- Francisco José Tarazona Santabalbina
- Ernesto Guerra-Farfán
- Jordi Teixidor Serra
- Jordi Tomas Hernandez
- Marc Aguilar Garcia
- Vicente Molero Garcia
- Sergi Barrera
- Jordi Selga
- Teresa Sanclemente
- Maria Villar
- Joan Bago
- Miriam Garrido
- Amar Rangan
- Birgit Hanusch
- Lucksy Kottam
- William Farrington
- Carol Greene
چکیده
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 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).
منابع مشابه
In-Hospital Outcomes after Hemiarthroplasty versus Total Hip Arthroplasty for Isolated Femoral Neck Fractures
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عنوان ژورنال:
دوره 5 شماره
صفحات -
تاریخ انتشار 2015