The Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)

The aim of this study was to inform a definitive trial which could determine the clinical effectiveness of the X-Bolt Dynamic Hip Plating System compared with the sliding hip screw for patients with complex pertrochanteric fragility fractures of the femur.This was a single centre, participant blinde...

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Main Authors: Griffin, X, Parsons, N, McArthur, J, Achten, J, Costa, M
Format: Journal article
Language:English
Published: British Editorial Society of Bone and Joint Surgery 2016
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author Griffin, X
Parsons, N
McArthur, J
Achten, J
Costa, M
author_facet Griffin, X
Parsons, N
McArthur, J
Achten, J
Costa, M
author_sort Griffin, X
collection OXFORD
description The aim of this study was to inform a definitive trial which could determine the clinical effectiveness of the X-Bolt Dynamic Hip Plating System compared with the sliding hip screw for patients with complex pertrochanteric fragility fractures of the femur.This was a single centre, participant blinded, randomised, standard-of-care controlled pilot trial. Patients aged 60 years and over with AO/ASIF A2 and A3 type femoral pertrochanteric fractures were eligible.The primary outcome was the EuroQoL 5 Dimension Score (EQ-5D-3L) at one year following index fixation. A total of 100 participants were recruited, and primary outcome data were available for 88 patients following losses to follow-up and withdrawals. The mean difference in EQ-5D was 0.03 (95% confidence interval -0.17, 0.120; p = 0.720.) There were no significant differences in any of the secondary outcomes measures. The recruitment and follow-up rates from this feasibility study were as predicted.A definitive trial with 90% power to find a clinically important difference in EQ-5D would require 964 participants based upon the data from this study. We plan to start recruitment to this trial in Spring 2016.A definitive trial of X-Bolt Dynamic Hip Plating System is feasible and should be conducted now in order to quantify the clinical effectiveness of this novel implant.
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spelling oxford-uuid:7ca51302-7e5a-4f47-8658-fe883bad65602022-03-26T20:58:24ZThe Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:7ca51302-7e5a-4f47-8658-fe883bad6560EnglishSymplectic Elements at OxfordBritish Editorial Society of Bone and Joint Surgery2016Griffin, XParsons, NMcArthur, JAchten, JCosta, MThe aim of this study was to inform a definitive trial which could determine the clinical effectiveness of the X-Bolt Dynamic Hip Plating System compared with the sliding hip screw for patients with complex pertrochanteric fragility fractures of the femur.This was a single centre, participant blinded, randomised, standard-of-care controlled pilot trial. Patients aged 60 years and over with AO/ASIF A2 and A3 type femoral pertrochanteric fractures were eligible.The primary outcome was the EuroQoL 5 Dimension Score (EQ-5D-3L) at one year following index fixation. A total of 100 participants were recruited, and primary outcome data were available for 88 patients following losses to follow-up and withdrawals. The mean difference in EQ-5D was 0.03 (95% confidence interval -0.17, 0.120; p = 0.720.) There were no significant differences in any of the secondary outcomes measures. The recruitment and follow-up rates from this feasibility study were as predicted.A definitive trial with 90% power to find a clinically important difference in EQ-5D would require 964 participants based upon the data from this study. We plan to start recruitment to this trial in Spring 2016.A definitive trial of X-Bolt Dynamic Hip Plating System is feasible and should be conducted now in order to quantify the clinical effectiveness of this novel implant.
spellingShingle Griffin, X
Parsons, N
McArthur, J
Achten, J
Costa, M
The Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)
title The Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)
title_full The Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)
title_fullStr The Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)
title_full_unstemmed The Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)
title_short The Warwick Hip Trauma Evaluation One: a randomised pilot trial comparing the X-Bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures: WHiTE (One)
title_sort warwick hip trauma evaluation one a randomised pilot trial comparing the x bolt dynamic hip plating system with sliding hip screw fixation in complex extracapsular hip fractures white one
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