Aims 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.
Patients and 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.
Conclusion 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.
Take home message: 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.
X. L. Griffin: Data analysis, Writing the paper.
N. Parsons: Design of study, Data analysis, Writing the paper.
J. McArthur: Writing the paper.
J. Achten: Protocol development, Trial management, Manuscript development.
M. L. Costa: Data analysis, Writing the paper.
This study was funded by X-Bolt Orthopaedics.
Benefits have been or will be directed to a research fund, foundation, educational institution, or other nonprofit organisation with which one or more of the authors are associated.
This article was primary edited by A. D. Liddle and first proof edited by G. Scott.
- Received September 29, 2015.
- Accepted January 13, 2016.
- ©2016 The British Editorial Society of Bone & Joint Surgery