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).
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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. Cite this article: Bone Joint J 2016;98-B:686-9.
authors.affiliation: Oxford University Hospitals NHS Foundation Trust, Headley Way, Oxford, OX3 9DU, UK.
authors.forename: X L
authors.initials: XL
authors.lastname: Griffin
authors.affiliation: University of Warwick, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK.
authors.forename: N
authors.initials: N
authors.lastname: Parsons
authors.affiliation: University Hospital Coventry, Clifford Bridge Road, CV2 2DX, UK.
authors.forename: J
authors.initials: J
authors.lastname: McArthur
authors.affiliation: University of Oxford , Headley Way, Oxford OX3 9DU, UK.
authors.forename: J
authors.initials: J
authors.lastname: Achten
authors.affiliation: University of Oxford , Headley Way, Oxford OX3 9DU, UK.
authors.forename: M L
authors.initials: ML
authors.lastname: Costa
mesh_terms: D001860:Bone Plates; D001863:Bone Screws; D005260:Female; D005593:Fracture Fixation, Internal / Q000295:instrumentation*; D006620:Hip Fractures / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012086:Reoperation; D016037:Single-Blind Method; D006113:United Kingdom
keywords: Hip fracture; Proximal femur; Quality of life; RCT; X-Bolt