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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Format: | Journal article |
Language: | English |
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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. |
first_indexed | 2024-03-07T00:21:19Z |
format | Journal article |
id | oxford-uuid:7ca51302-7e5a-4f47-8658-fe883bad6560 |
institution | University of Oxford |
language | English |
last_indexed | 2024-03-07T00:21:19Z |
publishDate | 2016 |
publisher | British Editorial Society of Bone and Joint Surgery |
record_format | dspace |
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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