Trial Status: Recruitment closed: April 2018
WHITE-four is an industrial trial funded by X-Bolt Orthopaedics
World Hip Trauma Evaluation Four
Fractures of the proximal femur (hip fractures) are one of the greatest challenges facing the medical community. In 1990, a global incidence of 1.31 million was reported and was associated with 740,000 deaths. Hip fractures constitute a heavy socioeconomic burden worldwide.
The X-Bolt dynamic plating system builds on the successful design features of the SHS (Sliding Hip Screw) by having a plate attached to the lateral femur and a single telescoping screw in the femoral head, but differs in the nature of the fixation in the head. Expanding flanges are deployed to engage and compress the surrounding cancellous bone improving fixation. Trochanteric fractures rely on the quality of fixation in the femoral head to prevent cut out and the poor bone quality encountered in the patients sustaining these fractures is often a contributor to failure.
This will be multi centre, multi-surgeon, parallel, two arm, randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study. The study will include a two-way superiority comparison between X-Bolt dynamic plating system and SHS. The trial is expected to last a total of 38 months.
It is expected that participant recruitment will take 18 months and final follow-up will be at 12 months post-surgery. Based upon 2013 data in the National Hip Fracture Database the involved units perform approximately 800 of such procedures per year.
The primary objective is:
- To quantify and draw inferences on observed differences in participants’ health status between the trial treatment groups at 4 months post-injury.
The secondary objectives are:
- To quantify and draw inferences on observed differences in the risk of all cause revision surgery within the first year post-injury between the trial treatment groups.
- To quantify and draw inferences on observed differences in the proportion of complications/radiographic changes within the first year post-injury between the trial treatment groups.
The study protocol publication can be found here.