High-dose dual-antibiotic loaded cement for hip hemiarthroplasty in the UK (WHiTE 8): a randomised controlled trial

High-dose dual-antibiotic loaded cement for hip hemiarthroplasty in the UK (WHiTE 8): a randomised controlled trial

Hip fracture is the most common injury requiring treatment in hospital. Controversy exists regarding the use of antibiotic loaded bone cement in hip fractures treated with hemiarthroplasty. We aimed to compare the rate of deep surgical site infection in patients receiving high-dose dual-antibiotic l...

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Bibliographic Details
Published in:The Lancet (British edition) Vol. 402; no. 10397; pp. 196 - 202
Main Authors: Agni, Nickil R, Costa, Matthew L, Achten, Juul, Peckham, Nicholas, Dutton, Susan J, Png, May Ee, Reed, Mike R
Format: Journal Article
Language:English
Published: England Elsevier Ltd 15-07-2023
Elsevier Limited
Subjects:
Aged
Anti-Bacterial Agents - therapeutic use
Antibiotics
Bone cements
Bone implants
Cement
Clinical trials
Disease control
Drug dosages
Fractures
Health services
Hemiarthroplasty
Hip
Hip Fractures - surgery
Hip joint
Hospitals
Humans
Medical records
Medical research
Middle Aged
Mobility
Mortality
Patients
Polymethyl methacrylate
Quality of Life
Randomization
Research facilities
Surgeons
Surgical site infections
Surgical Wound Infection - epidemiology
Trauma
United Kingdom
United Kingdom
United Kingdom > UK
Germany
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Summary:Hip fracture is the most common injury requiring treatment in hospital. Controversy exists regarding the use of antibiotic loaded bone cement in hip fractures treated with hemiarthroplasty. We aimed to compare the rate of deep surgical site infection in patients receiving high-dose dual-antibiotic loaded cement versus standard care single-antibiotic loaded cement. We included people aged 60 years and older with a hip fracture attending 26 UK hospitals in this randomised superiority trial. Participants undergoing cemented hemiarthroplasty were randomly allocated in a 1:1 ratio to either a standard care single-antibiotic loaded cement or high-dose dual-antibiotic loaded cement. Participants and outcome assessors were masked to the treatment allocation. The primary outcome was deep surgical site infection at 90 days post-randomisation as defined by the US Centers for Disease Control and Prevention in an as-randomised population of consenting participants with available data at 120 days. Secondary outcomes were quality of life, mortality, antibiotic use, mobility, and residential status at day 120. The trial is registered with ISRCTN15606075. Between Aug 17, 2018, and Aug 5, 2021, 4936 participants were randomly assigned to either standard care single-antibiotic loaded cement (2453 participants) or high-dose dual-antibiotic loaded cement (2483 participants). 38 (1·7%) of 2183 participants with follow-up data in the single-antibiotic loaded cement group had a deep surgical site infection by 90 days post-randomisation, as did 27 (1·2%) of 2214 participants in the high-dose dual-antibiotic loaded cement group (adjusted odds ratio 1·43; 95% CI 0·87–2·35; p=0·16). In this trial, the use of high-dose dual-antibiotic loaded cement did not reduce the rate of deep surgical site deep infection among people aged 60 years or older receiving a hemiarthroplasty for intracapsular fracture of the hip. Heraeus Medical. Supported by the UK National Institute for Health and Care Research Oxford Biomedical Research Centre.
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ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(23)00962-5