Quantification and severity grading of femoral vessel compression by adverse reactions to metal debris in metal-on-metal total hip arthroplasty.

INTRODUCTION: Metal-on-metal (MoM) total hip arthroplasty (THA) may cause adverse reactions to metal debris (ARMD). ARMD causing femoral vessel compression with serious complications has been described in case reports, but the rate of compression by ARMD is not known. This study aims to investigate the rate, and quantify the severity, of femoral vessel compression in MoM hips with ARMD lesions. METHODS: Patients under surveillance for MoM THA investigated with MRI were studied. In patients with confirmed ARMD, femoral artery (FA) and vein (FV) diameters were measured at the point of maximal compression and compared to contralateral vessels. The primary outcome measure was presence or absence of compression. Cases were then classified by compression ratios. Secondary outcome measures were rates of deep vein thrombosis, revision surgery and time to ARMD from index procedure. RESULTS: MRI scans for 436 patients with MoM THA were screened. Of these, 211/436 (48.4%) showed evidence of ARMD. Measurements were obtained on 133/211 (63.0%) patients. The FV was compressed in 102/133 (76.7%) and FA in 58/133 (43.6%), while 31/133 (23.3%) patients had no compression. In FVs, 42 demonstrated mild compression, 39 moderate and 21 severe. In FAs, none were severely compressed, 6 were moderate and 52 showed mild compression. There were 3 DVT cases, 2 in patients with moderate FV compression and 1 in patients without FV compression. Revision rates were highest in patients with severe FV compression (14/21, 66.7%). The mean time for MRI-diagnosed ARMD from index procedure was 8 years and 1 month (range 11 months-14.5 years). CONCLUSIONS: Extra-luminal compression of the femoral vessels was found in >75% of patients with ARMD. Although it is not clear whether revision for femoral vessel compression is required, quantification of FV compression may be useful for surgeons and radiologists considering revision for ARMD.

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

BACKGROUND: 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. METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: Heraeus Medical. Supported by the UK National Institute for Health and Care Research Oxford Biomedical Research Centre.

A randomized clinical trial of low dose single antibiotic-loaded cement versus high dose dual antibiotic-loaded cement in patients receiving a hip hemiarthroplasty after fracture: A protocol for the WHiTE 8 COPAL study.

AIMS: 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. METHODS: 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. CONCLUSION: The results of this trial will provide evidence regarding clinical and cost-effectiveness between low dose single and high dose dual antibiotic-loaded bone cement, which will inform policy and practice guidelines such as the National Institute for Health and Care Excellence guidance on management of hip fractures. Cite this article: Bone Jt Open 2021;2(2):72-78.

Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates.

Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.

Calcaneal Tuberosity Fixation Using a Locking Compression Hook Plate.

Calcaneal tuberosity fractures account for 1% to 3% of all calcaneal fractures. Surgical fixation is particularly challenging owing to osteoporosis and numerous comorbidities and risk factors in this patient population. Numerous techniques have been proposed; however, we describe the use of a locking compression hook plate in the treatment of type 2 fracture patterns. This has the advantage of providing stable fixation in osteoporotic bone, avoiding the disadvantages of soft tissue and metalwork irritation that have been described with other techniques.