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 on revision surgery rates and quality of life in the treatment of femoral neck fractures

Robert McCormack, Kelly Apostle, Dory Boyer, Farhad Moola, Bertrand Perey, Trevor Stone, Darius Viskontas, H. Michael Lemke, Mauri Zomar, Karyn Moon, Raely Moon, Amber Oatt, Richard E. Buckley, Paul Duffy, Robert Korley, Shannon Puloski, Kelly Johnston, James Powell, Kimberly Carcary, David Sanders & 31 others Abdel Lawendy, Christina Tieszer, David Stephen, Hans Kreder, Richard Jenkinson, Markku Nousiainen, Terry Axelrod, John Murnaghan, Diane Nam, Veronica Wadey, Albert Yee, Katrine Milner, Monica Kunz, Emil H. Schemitsch, Henry Ahn, Jeremy A. Hall, Michael D. McKee, Daniel B. Whelan, Aaron Nauth, Milena R. Vicente, Lisa M. Wild, Ryan M. Khan, Jennifer T. Hidy, Chad Coles, Peter A. Cole, Sarah A. Anderson, Paul M. Lafferty, Mengnai Li, Amy L. Foley, P. J. Devereaux, The FAITH Investigators

Research output: Contribution to journalArticle

13 Citations (Scopus)

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. Trial registration. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

Original languageEnglish (US)
Article number219
JournalBMC Musculoskeletal Disorders
Volume15
Issue number1
DOIs
StatePublished - Sep 26 2014

Fingerprint

Femoral Neck Fractures
Hip Fractures
Reoperation
Hip
Quality of Life
Orthopedics
Therapeutics
Benchmarking
Fracture Healing
Random Allocation
North America
Proportional Hazards Models
Randomized Controlled Trials
Mortality
Health
Population

Keywords

  • Cancellous screws
  • Femoral neck fractures
  • Fracture fixation
  • Hip fractures
  • Internal fixation
  • Sliding hip screw

Cite this

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 on revision surgery rates and quality of life in the treatment of femoral neck fractures. / McCormack, Robert; Apostle, Kelly; Boyer, Dory; Moola, Farhad; Perey, Bertrand; Stone, Trevor; Viskontas, Darius; Michael Lemke, H.; 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; Cole, Peter A.; Anderson, Sarah A.; Lafferty, Paul M.; Li, Mengnai; Foley, Amy L.; Devereaux, P. J.; The FAITH Investigators.

In: BMC Musculoskeletal Disorders, Vol. 15, No. 1, 219, 26.09.2014.

Research output: Contribution to journalArticle

McCormack, R, Apostle, K, Boyer, D, Moola, F, Perey, B, Stone, T, Viskontas, D, Michael Lemke, H, Zomar, M, Moon, K, Moon, R, Oatt, A, Buckley, RE, Duffy, P, Korley, R, Puloski, S, Johnston, K, Powell, J, Carcary, K, Sanders, D, Lawendy, A, Tieszer, C, Stephen, D, Kreder, H, Jenkinson, R, Nousiainen, M, Axelrod, T, Murnaghan, J, Nam, D, Wadey, V, Yee, A, Milner, K, Kunz, M, Schemitsch, EH, Ahn, H, Hall, JA, McKee, MD, Whelan, DB, Nauth, A, Vicente, MR, Wild, LM, Khan, RM, Hidy, JT, Coles, C, Cole, PA, Anderson, SA, Lafferty, PM, Li, M, Foley, AL, Devereaux, PJ & The FAITH Investigators 2014, '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 on revision surgery rates and quality of life in the treatment of femoral neck fractures', BMC Musculoskeletal Disorders, vol. 15, no. 1, 219. https://doi.org/10.1186/1471-2474-15-219
McCormack, Robert ; Apostle, Kelly ; Boyer, Dory ; Moola, Farhad ; Perey, Bertrand ; Stone, Trevor ; Viskontas, Darius ; Michael Lemke, H. ; 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 ; Cole, Peter A. ; Anderson, Sarah A. ; Lafferty, Paul M. ; Li, Mengnai ; Foley, Amy L. ; Devereaux, P. J. ; The FAITH Investigators. / 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 on revision surgery rates and quality of life in the treatment of femoral neck fractures. In: BMC Musculoskeletal Disorders. 2014 ; Vol. 15, No. 1.
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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. Trial registration. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).",
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author = "Robert McCormack and Kelly Apostle and Dory Boyer and Farhad Moola and Bertrand Perey and Trevor Stone and Darius Viskontas and {Michael Lemke}, H. and Mauri Zomar and Karyn Moon and Raely Moon and Amber Oatt and Buckley, {Richard E.} and Paul Duffy and Robert Korley and Shannon Puloski and Kelly Johnston and James Powell and Kimberly Carcary and David Sanders and Abdel Lawendy and Christina Tieszer and David Stephen and Hans Kreder and Richard Jenkinson and Markku Nousiainen and Terry Axelrod and John Murnaghan and Diane Nam and Veronica Wadey and Albert Yee and Katrine Milner and Monica Kunz and Schemitsch, {Emil H.} and Henry Ahn and Hall, {Jeremy A.} and McKee, {Michael D.} and Whelan, {Daniel B.} and Aaron Nauth and Vicente, {Milena R.} and Wild, {Lisa M.} and Khan, {Ryan M.} and Hidy, {Jennifer T.} and Chad Coles and Cole, {Peter A.} and Anderson, {Sarah A.} and Lafferty, {Paul M.} and Mengnai Li and Foley, {Amy L.} and Devereaux, {P. J.} and {The FAITH Investigators}",
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T1 - Fixation using alternative implants for the treatment of hip fractures (FAITH)

T2 - Design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

AU - McCormack, Robert

AU - Apostle, Kelly

AU - Boyer, Dory

AU - Moola, Farhad

AU - Perey, Bertrand

AU - Stone, Trevor

AU - Viskontas, Darius

AU - Michael Lemke, H.

AU - Zomar, Mauri

AU - Moon, Karyn

AU - Moon, Raely

AU - Oatt, Amber

AU - Buckley, Richard E.

AU - Duffy, Paul

AU - Korley, Robert

AU - Puloski, Shannon

AU - Johnston, Kelly

AU - Powell, James

AU - Carcary, Kimberly

AU - Sanders, David

AU - Lawendy, Abdel

AU - Tieszer, Christina

AU - Stephen, David

AU - Kreder, Hans

AU - Jenkinson, Richard

AU - Nousiainen, Markku

AU - Axelrod, Terry

AU - Murnaghan, John

AU - Nam, Diane

AU - Wadey, Veronica

AU - Yee, Albert

AU - Milner, Katrine

AU - Kunz, Monica

AU - Schemitsch, Emil H.

AU - Ahn, Henry

AU - Hall, Jeremy A.

AU - McKee, Michael D.

AU - Whelan, Daniel B.

AU - Nauth, Aaron

AU - Vicente, Milena R.

AU - Wild, Lisa M.

AU - Khan, Ryan M.

AU - Hidy, Jennifer T.

AU - Coles, Chad

AU - Cole, Peter A.

AU - Anderson, Sarah A.

AU - Lafferty, Paul M.

AU - Li, Mengnai

AU - Foley, Amy L.

AU - Devereaux, P. J.

AU - The FAITH Investigators

PY - 2014/9/26

Y1 - 2014/9/26

N2 - 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. Trial registration. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

AB - 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. Trial registration. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

KW - Cancellous screws

KW - Femoral neck fractures

KW - Fracture fixation

KW - Hip fractures

KW - Internal fixation

KW - Sliding hip screw

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JO - BMC Musculoskeletal Disorders

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