Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.Aims
Methods
One commonly used rat fracture model for bone and mineral research
is a closed mid-shaft femur fracture as described by Bonnarens in
1984. Initially, this model was believed to create very reproducible
fractures. However, there have been frequent reports of comminution
and varying rates of complication. Given the importance of precise
anticipation of those characteristics in laboratory research, we
aimed to precisely estimate the rate of comminution, its importance and
its effect on the amount of soft callus created. Furthermore, we
aimed to precisely report the rate of complications such as death
and infection. We tested a rat model of femoral fracture on 84 rats based on
Bonnarens’ original description. We used a proximal approach with
trochanterotomy to insert the pin, a drop tower to create the fracture
and a high-resolution fluoroscopic imager to detect the comminution.
We weighed the soft callus on day seven and compared the soft callus
parameters with the comminution status.Objectives
Methods
