WHiTE-8

Dedicated Trial Website

For more information on this trial, please visit the dedicated trial website by following the link below!

https://white8.octru.ox.ac.uk/

BACKGROUND

Fragility hip fractures present a significant global challenge to patients, clinicians and healthcare systems. The global literature confirms an overall mortality risk in the range 10-40% in the first year with much of this attributed to post-operative complications.

Surgical site infection (SSI) is a significant complication with literature for hemiarthroplasty infection stating rates as high as 7.3%. Therefore, the prevention of postoperative complications is likely to be one good way of reducing mortality in this group of patients.

Perioperative antibiotics are one proven means of reducing postoperative infection in patients undergoing hip arthroplasty for any indication. The current standard for cemented hip hemiarthroplasty is the use of parenteral antibiotics in combination with antibiotic loaded cement.

TRIAL DESIGN

This will be multi centre, multi-surgeon, parallel, two arm, randomised controlled trial. This will be embedded in the World Hip Trauma Evaluation (WHITE) comprehensive cohort.

All adult patients 60 years of age and over presenting at the trial centres, who in the opinion of the treating surgeon require acute surgical treatment with a cemented hip hemiarthroplasty are eligible for inclusion.

AIM

The aim of this pragmatic randomised controlled trial is to determine the rate of deep infection in patients treated with either low dose single antibiotic loaded cement or high dose dual antibiotic loaded cement for the treatment of hip fracture with a hemi-arthroplasty.

OBJECTIVES

The primary objective is:

To quantify and draw inferences on the rate of 'deep infection' within 90 days post hip fracture surgery in the low dose single and high dose dual groups.

The secondary objectives include quantifying and drawing inferences on observed differences in:

* Antibiotic prescription for hip wound issues within 90 days post hip fracture surgery

* Overall complication profile within 120 days post hip fracture surgery

* Health-related quality-of-life at 120 days post hip fracture surgery

* Mortality at 120 days post hip fracture surgery

* Mobility at 120 days post hip fracture surgery

* Antibiotic resistance profiles at 120 days post hip fracture surgery

* The resource use, costs and comparative cost effectiveness between interventions