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