Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws....

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McCormack, Robert
Apostle, Kelly
Boyer, Dory
Moola, Farhad
Perey, Bertrand
Stone, Trevor
Viskontas, Darius
Lemke, H Michael
Zomar, Mauri
Moon, Karyn
Moon, Raely
Oatt, Amber
Buckley, Richard E
Duffy, Paul
Korley, Robert
Puloski, Shannon
Johnston, Kelly
Powell, James
Carcary, Kimberly
Sanders, David
Lawendy, Abdel
Tieszer, Christina
Stephen, David
Kreder, Hans
Jenkinson, Richard
Nousiainen, Markku
Axelrod, Terry
Murnaghan, John
Nam, Diane
Wadey, Veronica
Yee, Albert
Milner, Katrine
Kunz, Monica
Schemitsch, Emil H
Ahn, Henry
Hall, Jeremy A
McKee, Michael D
Whelan, Daniel B
Nauth, Aaron
Vicente, Milena R
Wild, Lisa M
Khan, Ryan M
Hidy, Jennifer T
Coles, Chad
Leighton, Ross
Biddulph, Michael
Johnston, David
Glazebrook, Mark
Alexander, David
Coady, Cathy
Dunbar, Michael
Amirault, David
Gross, Michael
Oxner, William
Reardon, Gerald
Richardson, Glen
Trenholm, Andrew
Wong, Ivan
Trask, Kelly
MacDonald, Shelley
Dobbin, Gwen
Bicknell, Ryan
Yach, Jeff
Bardana, Davide
Wood, Gavin
Harrison, Mark
Yen, David
Lambert, Sue
Howells, Fiona
Ward, Angela
Zalzal, Paul
Brien, Heather
Naumetz, V
Weening, Brad
Simunovic, Nicole
Wai, Eugene K
Papp, Steve
Gofton, Wade T
Liew, Allen
Kingwell, Stephen P
Johnson, Garth
O'Neil, Joseph
Roffey, Darren M
Borsella, Vivian
Avram, Victoria
Oliver, Todd M
Jones, Vicki
Jones, Clifford B
Ringler, James R
Endres, Terrence J
Sietsema, Debra L
Jeray, Kyle J
Broderick, J Scott
Goetz, David R
Pace, Thomas B
Schaller, Thomas M
Porter, Scott E
Tanner, Stephanie L
Snider, Rebecca G
Nastoff, Lauren A
Bielby, Shea A
Switzer, Julie A
Cole, Peter A
Anderson, Sarah A
Lafferty, Paul M
Li, Mengnai
Ly, Thuan V
Marston, Scott B
Foley, Amy L
Vang, Sandy
Wright, David M
Marcantonio, Andrew J
Kain, Michael SH
Iorio, Richard
Specht, Lawrence M
Tilzey, John F
Lobo, Margaret J
Garfi, John S
Vallier, Heather A
Dolenc, Andrea
Robinson, Chalitha
Prayson, Michael J
Laughlin, Richard
Rubino, L Joseph
May, Jedediah
Rieser, Geoffrey Ryan
Dulaney-Cripe, Liz
Gayton, Chris
Shaer, James
Schrickel, Tyson
Hileman, Barbara
Gorczyca, John T
Gross, Jonathan M
Humphrey, Catherine A
Kates, Stephen
Noble, Krista
McIntyre, Allison W
Pecorella, Kaili
Davis, Craig A
Weinerman, Stewart
Weingarten, Peter
Stull, Philip
Lindenbaum, Stephen
Hewitt, Michael
Schwappach, John
Baker, Janell K
Rutherford, Tori
Newman, Heike
Lieberman, Shane
Finn, Erin
Robbins, Kristin
Hurley, Meghan
Lyle, Lindsey
Mitchell, Khalis
Browner, Kieran
Whatley, Erica
Payton, Krystal
Reeves, Christina
Cannada, Lisa K
Karges, David
Hill, Leslie
Mehta, Samir
Esterhai, John
Ahn, Jaimo
Horan, Annamarie D
McGinnis, Kelly
Kaminski, Christine A
Kowalski, Brynn N
Keeve, Jonathan P
Anderson, Christopher G
McDonald, Michael D
Hoffman, Jodi M
Tarkin, Ivan
Siska, Peter
Gruen, Gary
Evans, Andrew
Farrell, Dana J
Irrgang, James
Luther, Arlene
Cross, William W
Cass, Joseph R
Sems, Stephen A
Torchia, Michael E
Scrabeck, Tyson
Jenkins, Mark
Dumais, Jules
Romero, Amanda W
Sagebien, Carlos A
Butler, Mark S
Monica, James T
Seuffert, Patricia
Hsu, Joseph R
Ficke, James
Charlton, Michael
Napierala, Matthew
Fan, Mary
Tornetta, Paul
Tannoury, Chadi
Carlisle, Hope
Silva, Heather
Archdeacon, Michael
Finnan, Ryan
Le, Toan
Wyrick, John
Hess, Shelley
Brennan, Michael L
Probe, Robert
Kile, Evelyn
Mills, Kelli
Clipper, Lydia
Yu, Michelle
Erwin, Katie
Horwitz, Daniel
Strohecker, Kent
Swenson, Teresa K
Aurang, Kamran
Zohman, Gary
Peterson, Brett
Huff, Roger B
Baele, Joseph
Weber, Timothy
Edison, Matt
McBeth, Jessica
Shively, Karl
Ertl, Janos P
Mullis, Brian
Parr, J Andrew
Worman, Ripley
Frizzell, Valda
Moore, Molly M
Tobias, Erin
Thomas, Emily
DePaolo, Charles J
Alosky, Rachel
Shell, Leslie E
Hampton, Lynne
Shepard, Stephanie
Nanney, Tracy
Cuento, Claudine
Cantu, Robert V
Henderson, Eric R
Eickhoff, Linda S
Hammerberg, E Mark
Stahel, Philip
Hak, David
Mauffrey, Cyril
Gibula, Douglas
Gissel, Hannah
Henderson, Corey
Zamorano, David P
Tynan, Martin C
Pourmand, Deeba
Lawson, Deanna
Della Rocca, Gregory J
Crist, Brett D
Murtha, Yvonne M
Anderson, Linda K
Linehan, Colleen
Pilling, Lindsey
Lewis, Courtland G
Caminiti, Stephanie
Sullivan, Raymond J
Roper, Elizabeth
Obremskey, William
Kregor, Philip
Richards, Justin E
Stringfellow, Kenya
Dohm, Michael P
Zellar, Abby
Segers, Michiel JM
Zijl, Jacco AC
Verhoeven, Bart
Smits, Anke B
de Vries, Jean Paul PM
Fioole, Bram
van der Hoeven, Henk
Theunissen, Evert BM
Reilingh, Tammo S de Vries
Govaert, Lonneke
Wittich, Philippe
de Brauw, Maurits
Wille, Jan
Go, Peter MNYM
Ritchie, Ewan D
Wessel, Ronald N
Hammacher, Eric R
Heetveld, Martin J
Visser, Gijs A
Stockmann, Heyn
Silvis, Rob
Snellen, Jaap P
Rijbroek, Bram
Scheepers, Joris JG
Vermeulen, Erik GJ
Siroen, Michiel PC
Vuylsteke, Ronald
Brom, Hans LF
Rijna, Herman
de Rijcke, Piet AR
Koppert, Cees L
Buijk, Steven E
Groenendijk, Richard PR
Dawson, Imro
Tetteroo, Geert WM
Bruijninckx, Milko MM
Doornebosch, Pascal G
de Graaf, Eelco JR
van der Elst, Maarten
van der Pol, Carmen C
van 't Riet, Martijne
Karsten, Tom M
de Vries, Mark R
Stassen, Laurents PS
Schep, Niels WL
Ben Schmidt, G
Hoffman, WH
Poolman, Rudolf W
Simons, Maarten P
van der Heijden, Frank HWM
Willems, W Jaap
de Meulemeester, Frank RAJ
van der Hart, Cor P
Turckan, Kahn
Festen, Sebastiaan
de Nies, Frank
Haverlag, Robert
Out, Nico JM
Bosma, Jan
van Kampen, Albert
Biert, Jan
van Vugt, Arie B
Edwards, Michael JR
Blokhuis, Taco J
Frolke, Jan Paul M
Geeraedts, Leo MG
Gardeniers, Jean WM
Tan, Edward TCH
Poelhekke, Lodewijk MSJ
Malefijt, Maarten C de Waal
Schreurs, Bart
Roukema, Gert R
Josaputra, Hong A
Keller, Paul
de Rooij, Peter D
Kuiken, Hans
Boxma, Han
Cleffken, Berry I
Liem, Ronald
Rhemrev, Steven J
Bosman, Coks HR
van Otterloo, Alexander de Mol
Hoogendoorn, Jochem
de Vries, Alexander C
Meylaerts, Sven AG
Verhofstad, Michiel HJ
Meijer, Joost
van Egmond, Teun
van der Heijden, Frank HWM
van der Brand, Igor
Patka, Peter
Eversdijk, Martin G
Peters, Rolf
Den Hartog, Dennis
Van Waes, Oscar JF
Oprel, Pim
van der Vis, Harm M
Campo, Martin
Verhagen, Ronald
Albers, GH Robert
Zurcher, Arthur W
Simmermacher, Rogier KJ
van Mulken, Jeroen
van Wessem, Karlijn
Blokhuis, Taco J
van Gaalen, Steven M
Leenen, Luke PH
Bronkhorst, Maarten WGA
Guicherit, Onno R
Goslings, J Carel
Haverlag, Robert
Ponsen, Kees Jan
Bhatia, Mahesh
Arora, Vinod
Tyagi, Vivek
Liew, Susan
Bedi, Harvinder
Carr, Ashley
Curry, Hamish
Chia, Andrew
Csongvay, Steve
Donohue, Craig
Doig, Stephen
Edwards, Elton
Etherington, Greg
Esser, Max
Gong, Andrew
Jain, Arvind
Li, Doug
Miller, Russell
Moaveni, Ash
Russ, Matthias
Ton, Lu
Wang, Otis
Dowrick, Adam
Murdoch, Zoe
Sage, Claire
Frihagen, Frede
Clarke-Jenssen, John
Hjorthaug, Geir
Ianssen, Torben
Amundsen, Asgeir
Brattgjerd, Jan Egil
Borch, Tor
Boe, Berthe
Flatoy, Bernhard
Hasselund, Sondre
Haug, Knut Jorgen
Hemlock, Kim
Hoseth, Tor Magne
Jomaas, Geir
Kibsgard, Thomas
Lona, Tarjei
Moatshe, Gilbert
Muller, Oliver
Molund, Marius
Nicolaisen, Tor
Nilsen, Fredrik
Rydinge, Jonas
Smedsrud, Morten
Stodle, Are
Trommer, Axel
Ugland, Stein
Karlsten, Anders
Ekas, Guri
Vesterhus, Elise Berg
Brekke, Anne Christine
Gupta, Ajay
Jain, Neeraj
Khan, Farah
Sharma, Ateet
Sanghavi, Amir
Trivedi, Mittal
Rai, Anil
Subash
Rai, Kamal
Yadav, Vineet
Singh, Sanjay
Rai, Kamal
Tetsworth, Kevin
Donald, Geoff
Weinrauch, Patrick
Pincus, Paul
Yang, Steven
Halliday, Brett
Gervais, Trevor
Holt, Michael
Flynn, Annette
Prasad, Amal Shankar
Mishra, Vimlesh
Sundaresh, DC
Khanna, Angshuman
Cherian, Joe Joseph
Olakkengil, Davy J
Sharma, Gaurav
Pirpiris, Marinis
Love, David
Bucknill, Andrew
Farrugia, Richard J
Pape, Hans-Christoph
Knobe, Matthias
Pfeifer, Roman
Hull, Peter
Lewis, Sophie
Evans, Simone
Nanda, Rajesh
Logishetty, Rajanikanth
Anand, Sanjeev
Bowler, Carol
Dadi, Akhil
Palla, Naveen
Ganguly, Utsav
Rai, B Sachidananda
Rajakumar, Janakiraman
Jennings, Andrew
Chuter, Graham
Rose, Glynis
Horner, Gillian
Clark, Callum
Eke, Kate
Reed, Mike
Herriott, Chris
Dobb, Christine
Bhandari, Mohit
Swiontkowski, Marc
Devereaux, Pj
Schemitsch, Emil H
Heetveld, Martin J
Jeray, Kyle
Liew, Susan
Thabane, Lehana
Walter, Stephen
Sprague, Sheila
Scott, Taryn
Guyatt, Gordon
Bhandari, Mohit
Swiontkowski, Marc
Devereaux, Pj
Guyatt, Gordon
Heetveld, Martin J
Jeray, Kyle
Liew, Susan
Schemitsch, Emil H
Thabane, Lehana
Walter, Stephen
Bhandari, Mohit
Sprague, Sheila
Viveiros, Helena
McKay, Paula
Scott, Taryn
Swinton, Marilyn
Truong, Victoria
Koo, Kaitlin
Heels-Ansdell, Diane
Zhou, Qi
Buckingham, Lisa
Duraikannan, Aravin
Maddock, Deborah
Simunovic, Nicole
Swiontkowski, Marc
Agel, Julie
Heetveld, Martin J
Van Lieshout, Esther MM
Zielinski, Stephanie M
Rangan, Amar
Hanusch, Birgit C
Kottam, Lucksy
Clarkson, Rachel
Della Rocca, Gregory J
Haverlag, Robert
Liew, Susan
Slobogean, Gerard
Katz, Jeffrey
Gillespie, Brenda
Greendale, Gail A
Guy, Pierre
Hartman, Curtis
Rubin, Craig
Waddell, James
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2014
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Abstract

Background Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. Methods/Design FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. Discussion This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials.

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BMC Musculoskeletal Disorders

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2014

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15

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© 2014 The FAITH Investigators; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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