To compare the cost-utility of standard dressing with incisional negative-pressure wound therapy (iNPWT) in adults with closed surgical wounds associated with major trauma to the lower limbs. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective based on data collected from the Wound Healing in Surgery for Trauma (WHiST) multicentre randomized clinical trial. Health resource utilization was collected over a six-month post-randomization period using trial case report forms and participant-completed questionnaires. Cost-utility was reported in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was conducted to test the robustness of cost-effectiveness estimates while uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.Aims
Methods
Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre.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
A pragmatic, single-centre, double-blind randomized clinical trial was conducted in a NHS teaching hospital to evaluate whether there is a difference in functional knee scores, quality-of-life outcome assessments, and complications at one-year after intervention between total knee arthroplasty (TKA) and patellofemoral arthroplasty (PFA) in patients with severe isolated patellofemoral arthritis. This parallel, two-arm, superiority trial was powered at 80%, and involved 64 patients with severe isolated patellofemoral arthritis. The primary outcome measure was the functional section of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 months. Secondary outcomes were the full 24-item WOMAC, Oxford Knee Score (OKS), American Knee Society Score (AKSS), EuroQol five dimension (EQ-5D) quality-of-life score, the University of California, Los Angeles (UCLA) Physical Activity Rating Scale, and complication rates collected at three, six, and 12 months. For longer-term follow-up, OKS, EQ-5D, and self-reported satisfaction score were collected at 24 and 60 months.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
Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment. This was a multicentre, two-arm, open-label, parallel-group randomized controlled feasibility trial. Patients with a fracture of the distal radius aged 16 years and over were recruited from four centres in the UK and randomized (1:1) to receive a Woodcast or fibreglass cast. Data were collected on participant recruitment and retention, clinical efficacy, safety, and patient acceptability.Aims
Methods
The aim of this study was to estimate the cost-effectiveness of negative-pressure wound therapy (NPWT) in comparison with standard wound management after initial surgical wound debridement in adults with severe open fractures of the lower limb. An economic evaluation was conducted from the perspective of the United Kingdom NHS and Personal Social Services, based on evidence from the 460 participants in the Wound Management of Open Lower Limb Fractures (WOLLF) trial. Economic outcomes were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Bivariate regression of costs (given in £, 2014 to 2015 prices) and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained associated with NPWT dressings. Sensitivity and subgroup analyses were undertaken to assess the impacts of uncertainty and heterogeneity, respectively, surrounding aspects of the economic evaluation.Aims
Patients and Methods
Bone health assessment and the prescription of medication for secondary fracture prevention have become an integral part of the acute management of patients with hip fracture. However, there is little evidence regarding compliance with prescription guidelines and subsequent adherence to medication in this patient group. The World Hip Trauma Evaluation (WHiTE) is a multicentre, prospective cohort of hip fracture patients in NHS hospitals in England and Wales. Patients aged 60 years and older who received operative treatment for a hip fracture were eligible for inclusion in WHiTE. The prescription of bone protection medications was recorded from participants’ discharge summaries, and participant-reported use of bone protection medications was recorded at 120 days following surgery.Aims
Patients and Methods
This study explores data quality in operation type and fracture classification recorded as part of a large research study and a national audit with an independent review. At 17 centres, an expert surgeon reviewed a randomly selected subset of cases from their centre with regard to fracture classification using the AO system and type of operation performed. Agreement for these variables was then compared with the data collected during conduct of the World Hip Trauma Evaluation (WHiTE) cohort study. Both types of surgery and fracture classification were collapsed to identify the level of detail of reporting that achieved meaningful agreement. In the National Hip Fracture Database (NHFD), the types of operation and fracture classification were explored to identify the proportion of “highly improbable” combinations.Aims
Patients and Methods
The aim of this study was to compare the clinical effectiveness of Kirschner wire (K-wire) fixation with locking-plate fixation for patients with a dorsally displaced fracture of the distal radius in the five years after injury. We report the five-year follow-up of a multicentre, two-arm, parallel-group randomized controlled trial. A total of 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation were recruited from 18 trauma centres in the United Kingdom. Patients were excluded if the surface of the wrist joint was so badly displaced it required open reduction. In all, 448 patients were randomized to receive either K-wire fixation or locking-plate fixation. In the K-wire group, there were 179 female and 38 male patients with a mean age of 59.1 years (19 to 89). In the locking-plate group, there were 194 female and 37 male patients with a mean age of 58.3 years (20 to 89). The primary outcome measure was the patient-rated wrist evaluation (PRWE). Secondary outcomes were health-related quality of life using the EuroQol five-dimension three-level (EQ-5D-3L) assessment, and further surgery related to the index fracture.Aims
Patients and Methods
This study sought to determine the proportion of older adults with hip fractures captured by a multicentre prospective cohort, the World Hip Trauma Evaluation (WHiTE), whether there was evidence of selection bias during WHiTE recruitment, and the extent to which the WHiTE cohort is representative of the broader population of older adults with hip fractures. The characteristics of patients recruited into the WHiTE cohort study were compared with those treated at WHiTE hospitals during the same timeframe and submitted to the National Hip Fracture Database (NHFD).Aims
Patients and Methods
The aim of this study was to compare the cost-effectiveness of
intramedullary nail fixation and ‘locking’ plate fixation in the
treatment of extra-articular fractures of the distal tibia. An economic evaluation was conducted from the perspective of
the United Kingdom National Health Service (NHS) and personal social
services (PSS), based on evidence from the Fixation of Distal Tibia
Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients
were available for analysis. Costs were collected prospectively
over the 12-month follow-up period 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, and net monetary benefit. Sensitivity analyses
were conducted to test the robustness of cost-effectiveness estimates.Aim
Patients and Methods
The aim of this study was to explore the patients’ experience
of recovery from open fracture of the lower limb in acute care. A purposeful sample of 20 participants with a mean age of 40
years (20 to 82) (16 males, four females) were interviewed a mean
of 12 days (five to 35) after their first surgical intervention took
place between July 2012 and July 2013 in two National Health Service
(NHS) trusts in England, United Kingdom. The qualitative interviews
drew on phenomenology and analysis identified codes, which were
drawn together into categories and themes.Aims
Patients and Methods
This study aimed to compare the change in health-related quality
of life of patients receiving a traditional cemented monoblock Thompson
hemiarthroplasty compared with a modern cemented modular polished-taper
stemmed hemiarthroplasty for displaced intracapsular hip fractures. This was a pragmatic, multicentre, multisurgeon, two-arm, parallel
group, randomized standard-of-care controlled trial. It was embedded
within the WHiTE Comprehensive Cohort Study. The sample size was
964 patients. The setting was five National Health Service Trauma
Hospitals in England. A total of 964 patients over 60 years of age who
required hemiarthroplasty of the hip between February 2015 and March
2016 were included. A standardized measure of health outcome, the
EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and
at four months following the operation.Aims
Patients and 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 aim of this study was to compare the effectiveness of a femoral
nerve block and a periarticular infiltration in the management of
early post-operative pain after total knee arthroplasty (TKA). A pragmatic, single centre, two arm parallel group, patient blinded,
randomised controlled trial was undertaken. All patients due for
TKA were eligible. Exclusion criteria included contraindications
to the medications involved in the study and patients with a neurological
abnormality of the lower limb. Patients received either a femoral
nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around
the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine
hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol
and 0.25 mg of adrenaline all diluted with 0.9% saline to make a
volume of 150 ml.Aims
Patients and 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
Traditionally, informed consent for clinical
research involves the patient reading an approved Participant Information
Sheet, considering the information presented and having as much time
as they need to discuss the study information with their friends
and relatives, their clinical care and the research teams. This
system works well in the ‘planned’ or ‘elective’ setting. But what
happens if the patient requires urgent treatment for an injury or emergency? This article reviews the legal framework which governs informed
consent in the emergency setting, discusses how the approach taken
may vary according to the details of the emergency and the treatment
required, and reports on the patients’ view of providing consent
following a serious injury. We then provide some practical tips
for managing the process of informed consent in the context of injuries
and emergencies. Cite this article:
The optimal treatment for independent patients with a displaced
intracapsular fracture of the hip remains controversial. The recognised
alternatives are hemiarthroplasty and total hip arthroplasty. At
present there is no established standard of care, with both types
of arthroplasty being used in many centres. We conducted a feasibility study comparing the clinical effectiveness
of a dual mobility acetabular component compared with standard polyethylene
component in total hip arthroplasty for independent patients with
a displaced intracapsular fracture of the hip, for a 12-month period
beginning in June 2013. The primary outcome was the risk of dislocation
one year post-operatively. Secondary outcome measures were EuroQol
5 Dimensions, ICEpop CAPability measure for Older people, Oxford
hip score, mortality and re-operation.Aims
Patients and Methods
