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
The cement used for hemiarthroplasties by the authors and many other surgeons in the UK is Palacos® (containing 0.5g Gentamicin). Similar cement, Copal® (containing 1g Gentamicin and 1g Clindamycin) has been used in revision arthroplasties. We aim to investigate the effect on SSI rates of doubling the gentamicin dose and adding a second antibiotic (clindamycin) to the bone cement in hip hemiarthroplasty. We randomised 848 consecutive patients undergoing cemented hip hemiarthroplasty for fractured NOF into two groups: Group I, 464 patients, received standard cement (Palacos®) and Group II, 384 patients, received high dose, double antibiotic-impregnated cement (Copal®). We calculated the SSI rate for each group at 30 days post-surgery. The patients, reviewers and statistician were blinded as to treatment group. The demographics and co-morbid conditions were statistically similar between the groups. The combined superficial and deep SSI rates were 5 % (20/394) and 1.7% (6/344) for groups I and II respectively (p=0.01). Group I had a deep infection rate 3.3 %(13/394) compared to 1.16% (4/344) in group II (p=0.082). Group I had a superficial infection rate 1.7 % (7/394) compared to 0.58% (2/344) in group II (p=0.1861). 33(4%) patients were lost to follow up, and 77 (9%) patients were deceased at the 30 day end point. Using high dose double antibiotic-impregnated cement rather than standard low dose antibiotic-impregnated cement significantly reduced the SSI rate (1.7% vs 5%; p=0.01) after hip hemiarthroplasty for fractured neck of femur in this prospective randomised controlled trial.
Medical complications and death are rare events following elective orthopaedic surgery. Diagnostic and operative codes are routinely collected on every patient admitted to hospital in the English NHS (hospital episode statistics, HES). This is the first study investigating rates of these events following total joint replacement (TJR) on a national scale in the NHS. All patients (585177 patients) who underwent TJR (hip arthroplasty [THR], knee arthroplasty [TKR], or hip resurfacing) between January 2005 and February 2010 in the English NHS were identified. Patients were subdivided based on Charlson co-morbidity score. HES data in the form of OPCS and ICD-10 codes were used to establish 30-day medical complication rates from myocardial infarction (MI), cerebrovascular event (CVA), chest infection (LRTI), renal failure (RF), pulmonary embolus (PE) and inpatient 90-day mortality (MR).Background
Methods
From August 2009, all doctors were subject to the European Working Time Directive (EWTD) restrictions of 48 hours of work per week. Changes to rota patterns have been introduced over the last two years to accommodate for these impending changes, sacrificing ‘normal working hours’ training opportunities for out-of-hours service provision. We have analysed the elogbook data to establish whether operative experience has been affected. A survey of trainees (ST3-8) was performed in February 2009 to establish shift patterns in units around the UK. All operative data entered into the elogbook during 2008 at these units was analysed according to type of shift (24hr on call with normal work the following day, 24hr on call then off next working day, or shifts including nights). 66% of units relied on traditional 24hrs on call in February 2009. When compared with these units, trainees working shifts had 18% less operative experience (564 to 471 operations) over the six years of training, with a 51% reduction in elective experience (288 to 140 operations). In the mid years of training, between ST3-5, operative experience fell from 418 to 302 operations (25% reduction) when shifts were introduced. This national data reflects the situation in UK hospitals in 2009, prior to the implementation of a maximum of 48 hours. It is expected that most hospitals will need to convert to shift-type working patterns to fall within the law. This could have significant implications for elective orthopaedic training in the UK.
