TY - JOUR
T1 - Fracture fixation in the operative management of hip fractures (FAITH)
T2 - an international, multicentre, randomised controlled trial
AU - Nauth, Aaron
AU - Creek, Aaron T.
AU - Zellar, Abby
AU - Lawendy, Abdel Rahman
AU - Dowrick, Adam
AU - Gupta, Ajay
AU - Dadi, Akhil
AU - van Kampen, Albert
AU - Yee, Albert
AU - de Vries, Alexander C.
AU - de Mol van Otterloo, Alexander
AU - Garibaldi, Alisha
AU - Liew, Allen
AU - McIntyre, Allison W.
AU - Prasad, Amal Shankar
AU - Romero, Amanda W.
AU - Rangan, Amar
AU - Oatt, Amber
AU - Sanghavi, Amir
AU - Foley, Amy L.
AU - Karlsten, Anders
AU - Dolenc, Andrea
AU - Bucknill, Andrew
AU - Chia, Andrew
AU - Evans, Andrew
AU - Gong, Andrew
AU - Schmidt, Andrew H.
AU - Marcantonio, Andrew J.
AU - Jennings, Andrew
AU - Ward, Angela
AU - Khanna, Angshuman
AU - Rai, Anil
AU - Smits, Anke B.
AU - Horan, Annamarie D.
AU - Brekke, Anne Christine
AU - Flynn, Annette
AU - Duraikannan, Aravin
AU - Stødle, Are
AU - van Vugt, Arie B.
AU - Luther, Arlene
AU - Zurcher, Arthur W.
AU - Jain, Arvind
AU - Amundsen, Asgeir
AU - Moaveni, Ash
AU - Carr, Ashley
AU - Switzer, Julie A.
AU - Swiontkowski, Marc
AU - Lafferty, Paul M.
AU - Cole, Peter A.
AU - Marston, Scott B.
AU - Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) Investigators
N1 - Publisher Copyright:
© 2017 Elsevier Ltd
PY - 2017/4/15
Y1 - 2017/4/15
N2 - Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63–1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06–3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0·41) and sepsis (seven [1%] vs six [1%]; p=0·79). Interpretation In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians' Services Incorporated.
AB - Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63–1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06–3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0·41) and sepsis (seven [1%] vs six [1%]; p=0·79). Interpretation In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians' Services Incorporated.
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U2 - 10.1016/S0140-6736(17)30066-1
DO - 10.1016/S0140-6736(17)30066-1
M3 - Article
C2 - 28262269
AN - SCOPUS:85014150802
SN - 0140-6736
VL - 389
SP - 1519
EP - 1527
JO - The Lancet
JF - The Lancet
IS - 10078
ER -