The aim of this study was to compare the cost-effectiveness of cemented hemiarthroplasty (HA) versus hydroxyapatite-coated uncemented HA for the treatment of displaced intracapsular hip fractures in older adults. A within-trial economic evaluation was conducted based on data collected from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized controlled trial in the UK. Resource use was measured over 12 months post-randomization using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY) gained from the NHS and personal social service perspective. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was represented graphically using confidence ellipses and cost-effectiveness acceptability curves.Aims
Methods
The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 106 PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%.Aims
Methods
The aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients. This was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the “Best Practice Tariff” indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients.Aims
Methods
Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures.Aims
Methods
To assess the variation in pre-fracture quality of life (QoL) within the UK hip fracture population, and quantify the nature and strength of associations between QoL and other routinely collected patient characteristics and treatment choices. The World Hip Trauma Evaluation (WHiTE) study, an observational cohort study of UK hip fracture patients, collects a range of routine data and a health-related QoL score (EuroQol five-dimension questionnaire (EQ-5D)). Pre-fracture QoL data are summarized and statistical models fitted to understand associations between QoL, patient characteristics, fracture types, and operations.Aims
Methods
This feasibility study investigates the utilization and cost of health resources related to formal and informal care, home adaptations, and physiotherapy among patients aged 60 years and above after hip fracture from a multicentre cohort study (World Hip Trauma Evaluation (WHiTE)) in the UK. A questionnaire containing health resource use was completed at baseline and four months post-injury by patients or their carer. Completion rate and mean cost of each health resource item were assessed and sensitivity analysis was performed to derive a conservative estimate of the informal care cost. All costs are presented in 2017/18 pound sterling.Aims
Methods
This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial. A within-trial cost-utility analysis (CUA) will be conducted at four months postinjury from a health system (National Health Service and personal social services) perspective. Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months. Sensitivity analysis will be conducted to assess the robustness of the results.Aim
Methods
This study investigates the reporting of health-related quality of life (HRQoL) in patients following hip fracture. We compare the relative merits and make recommendations for the use for two methods of measuring HRQoL; (i) including patients who died during follow-up and (ii) including survivors only. The World Hip Trauma Evaluation has previously reported changes in HRQoL using EuroQol-5D for patients with hip fractures. We performed additional analysis to investigate the effect of including or excluding those patients who died during the first four months of the follow-up period.Objectives
Methods
The Sliding Hip Screw (SHS) is commonly used to treat trochanteric hip fractures. Fixation failure is a devastating complication requiring complex revision surgery. One mode of fixation failure is lag screw cut-out which is greatest in unstable fracture patterns and when the tip-apex distance of the lag screw is > 25 mm. The X-Bolt Dynamic Hip Plating System (X-Bolt Orthopaedics, Dublin, Ireland) is a new device which aims to reduce this risk of cut-out. However, some surgeons have reported difficulty minimising the tip-apex distance with subsequent concerns that this may lead to an increased risk of cut-out. We measured the tip-apex distance from the intra-operative radiographs of 93 unstable trochanteric hip fractures enrolled in a randomised controlled trial (Warwick Hip Trauma Evaluation, WHiTE One trial). Participants were treated with either the sliding hip screw or the X-Bolt dynamic hip plating system. We also recorded the incidence of cut-out in both groups, at a median follow-up time of 17 months.Objectives
Patients and Methods
The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. Recent guidance from The National Institute for Health and Clinical Excellence (NICE) states that research into the clinical and cost effectiveness of total hip arthroplasty (THA) as a treatment for hip fracture is a priority. We asked the question: can a trial investigating THA for hip fracture currently be delivered in the NHS? We performed a contemporaneous process evaluation that provides a context for the interpretation of the findings of WHiTE Two – a randomised study of THA for hip fracture. We developed a mixed methods approach to situate the trial centre within the context of wider United Kingdom clinical practice. We focused on fidelity, implementation, acceptability and feasibility of both the trial processes and interventions to stakeholder groups, such as healthcare providers and patients.Objectives
Methods
The lack of a consensus for core health outcomes
that should be reported in clinical research has hampered study design
and evidence synthesis. We report a United Kingdom consensus for
a core outcome set (COS) for clinical trials of patients with a
hip fracture. We adopted a modified nominal group technique to derive consensus
on 1) which outcome domains should be measured, and 2) methods of
assessment. Participants reflected a diversity of perspectives and
experience. They received an evidence synthesis and postal questionnaire
in advance of the consensus meeting, and ranked the importance of
candidate domains and the relevance and suitability of short-listed
measures. During the meeting, pre-meeting source data and questionnaire
responses were summarised, followed by facilitated discussion and
a final plenary session. A COS was determined using a closed voting
system: a 70% consensus was required. Consensus supported a five-domain COS: mortality, pain, activities
of daily living, mobility, and health-related quality of life (HRQL).
Single-item measures of mortality and mobility (indoor/outdoor walking
status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D
- were recommended. These measures should be included as a minimum
in all hip fracture trials. Other outcome measures should be added
depending on the particular interventions being studied. Cite this article:
We aimed to determine the effect of surgical approach on the
histology of the femoral head following resurfacing of the hip. We performed a histological assessment of the bone under the
femoral component taken from retrieval specimens of patients having
revision surgery following resurfacing of the hip. We compared the
number of empty lacunae in specimens from patients who had originally
had a posterior surgical approach with the number in patients having alternative
surgical approaches.Objectives
Methods
To study the vascularity and bone metabolism of the femoral head/neck
following hip resurfacing arthroplasty, and to use these results
to compare the posterior and the trochanteric-flip approaches. In our previous work, we reported changes to intra-operative
blood flow during hip resurfacing arthroplasty comparing two surgical
approaches. In this study, we report the vascularity and the metabolic
bone function in the proximal femur in these same patients at one
year after the surgery. Vascularity and bone function was assessed
using scintigraphic techniques. Of the 13 patients who agreed to
take part, eight had their arthroplasty through a posterior approach
and five through a trochanteric-flip approach.Objectives
Methods
We used Laser Doppler flowmetry to measure the effect on the blood flow to the femoral head/neck junction of two surgical approaches during resurfacing arthroplasty. We studied 24 hips undergoing resurfacing arthroplasty for osteoarthritis. Of these, 12 had a posterior approach and 12 a trochanteric flip approach. A Laser probe was placed under radiological control in the superolateral part of the femoral head/neck junction. The Doppler flux was measured at stages of the operation and compared with the initial flux. In both groups the main fall in blood flow occurred during the initial exposure and capsulotomy of the hip joint. There was a greater reduction in blood flow with the posterior (40%) than with the trochanteric flip approach (11%).
