TY - JOUR
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 - The FAITH Investigators
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 - Leighton, Ross
AU - Biddulph, Michael
AU - Johnston, David
AU - Glazebrook, Mark
AU - Alexander, David
AU - Rubin, Craig
N1 - Publisher Copyright:
© 2014The FAITH Investigators; licensee BioMed Central Ltd.
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
UR - http://www.scopus.com/inward/record.url?scp=84908283047&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84908283047&partnerID=8YFLogxK
U2 - 10.1186/1471-2474-15-219
DO - 10.1186/1471-2474-15-219
M3 - Article
C2 - 24965132
AN - SCOPUS:84908283047
SN - 1471-2474
VL - 15
JO - BMC musculoskeletal disorders
JF - BMC musculoskeletal disorders
IS - 1
M1 - 219
ER -