@article{3868ef54d0b64ccba22b0028542d2943,
title = "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",
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).",
keywords = "Cancellous screws, Femoral neck fractures, Fracture fixation, Hip fractures, Internal fixation, Sliding hip screw",
author = "{The FAITH Investigators} and 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 Ross Leighton and Michael Biddulph and David Johnston and Mark Glazebrook and David Alexander and Sems, {Stephen A.}",
note = "Funding Information: Research grants were received from the following: Canadian Institutes of Health Research (CIHR) (PI: Mohit Bhandari); National Institutes of Health (NIH) (PI: Marc Swiontkowski); Stichting NutsOhra (PI: Martin J Heetveld), The Netherlands Organisation for Health Research and Development (PI: Esther M M Van Lieshout); Physicians{\textquoteright} Services Incorporated (PI: Mohit Bhandari). Dr. Bhandari was also funded, in part, by a Canada Research Chair in Musculoskeletal Trauma which is unrelated to the present study (McMaster University, Hamilton, ON, Canada). We would also like to acknowledge the support of The County Durham & Tees Valley Comprehensive Local Research Network which operates as part of the National Institute for Health Research Comprehensive Clinical Research Network in England. The funding sources and study sponsor had no role in design or conduct of the study; the collection, management, analysis, or interpretation of the data; or writing of the report or the decision to submit the report for publication. Dr. Mohit Bhandari had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Publisher Copyright: {\textcopyright} 2014The FAITH Investigators; licensee BioMed Central Ltd.",
year = "2014",
month = sep,
day = "26",
doi = "10.1186/1471-2474-15-219",
language = "English (US)",
volume = "15",
journal = "BMC Musculoskeletal Disorders",
issn = "1471-2474",
publisher = "BioMed Central",
number = "1",
}