The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial. The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and health-related quality of life, chronic pain scores and neuropathic pain scores annually, using a self-reported questionnaire. Complications, including further surgery related to the fracture, were also recorded.Aims
Methods
Weightbearing instructions after musculoskeletal injury or orthopaedic surgery are a key aspect of the rehabilitation pathway and prescription. The terminology used to describe the weightbearing status of the patient is variable; many different terms are used, and there is recognition and evidence that the lack of standardized terminology contributes to confusion in practice. A consensus exercise was conducted involving all the major stakeholders in the patient journey for those with musculoskeletal injury. The consensus exercise primary aim was to seek agreement on a standardized set of terminology for weightbearing instructions.Aims
Methods
Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are subgroups of patients who may benefit from the alternative operation of a modern uncemented hemiarthroplasty – the aim of this study was to investigate this issue. Knowledge about the heterogeneity of treatment effects is important for surgeons in order to target operations towards specific subgroups who would benefit the most. We used causal forest analysis to compare subgroup- and individual-level treatment effects between cemented and modern uncemented hemiarthroplasty in patients aged > 60 years with an intracapsular fracture of the hip, using data from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized clinical trial. EuroQol five-dimension index scores were used to measure health-related quality of life at one, four, and 12 months postoperatively.Aims
Methods
The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.Aims
Methods
To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment. Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.Aims
Methods
There is a lack of published evidence relating to the rate of nonunion seen in occult scaphoid fractures, diagnosed only after MRI. This study reports the rate of delayed union and nonunion in a cohort of patients with MRI-detected acute scaphoid fractures. This multicentre cohort study at eight centres in the UK included all patients with an acute scaphoid fracture diagnosed on MRI having presented acutely following wrist trauma with normal radiographs. Data were gathered retrospectively for a minimum of 12 months at each centre. The primary outcome measures were the rate of acute surgery, delayed union, and nonunion.Aims
Methods
National hip fracture registries audit similar aspects of care but there is variation in the actual data collected; these differences restrict international comparison, benchmarking, and research. The Fragility Fracture Network (FFN) published a revised minimum common dataset (MCD) in 2022 to improve consistency and interoperability. Our aim was to assess compatibility of existing registries with the MCD. We compared 17 hip fracture registries covering 20 countries (Argentina; Australia and New Zealand; China; Denmark; England, Wales, and Northern Ireland; Germany; Holland; Ireland; Japan; Mexico; Norway; Pakistan; the Philippines; Scotland; South Korea; Spain; and Sweden), setting each of these against the 20 core and 12 optional fields of the MCD.Aims
Methods
To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial. The FixDT trial reported the results for 321 patients randomized to nail or locking plate fixation in the first 12 months after their injury. In this follow-up study, we report the results of 170 of the original participants who agreed to be followed up until five years. Participants reported their Disability Rating Index (DRI) and health-related quality of life (EuroQol five-dimension three-level questionnaire) annually by self-reported questionnaire. Further surgical interventions related to the fracture were also recorded.Aims
Methods
Musculoskeletal diseases are having a growing impact worldwide. It is therefore crucial to have an evidence base to most effectively and efficiently implement future health services across different healthcare systems. International trials are an opportunity to address these challenges and have many potential benefits. They are, however, complex to set up and deliver, which may impact on the efficient and timely delivery of a project. There are a number of models of how international trials are currently being delivered across a range of orthopaedic patient populations, which are discussed here. The examples given highlight that the key to overcoming these challenges is the development of trusted and equal partnerships with collaborators in each country. International trials have the potential to address a global burden of disease, and in turn optimize the benefit to patients in the collaborating countries and those with similar health services and care systems. Cite this article:
The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.Aims
Methods
The aim of this study was to compare the cost-effectiveness of surgical fixation with Kirschner (K-)wire ersus moulded casting after manipulation of a fracture of the distal radius in an operating theatre setting. An economic evaluation was conducted based on data collected from the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) multicentre randomized controlled trial in the UK. Resource use was collected at three, six, and 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 an NHS and personal social services perspective. Sensitivity analyses were conducted to examine the robustness of cost-effectiveness estimates, and decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.Aims
Methods
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 this study was to explore current use of the Global Fragility Fracture Network (FFN) Minimum Common Dataset (MCD) within established national hip fracture registries, and to propose a revised MCD to enable international benchmarking for hip fracture care. We compared all ten established national hip fracture registries: England, Wales, and Northern Ireland; Scotland; Australia and New Zealand; Republic of Ireland; Germany; the Netherlands; Sweden; Norway; Denmark; and Spain. We tabulated all questions included in each registry, and cross-referenced them against the 32 questions of the MCD dataset. Having identified those questions consistently used in the majority of national audits, and which additional fields were used less commonly, we then used consensus methods to establish a revised MCD.Aims
Methods
The aim of this study was to report the outcomes of patients with severe open fractures of the lower limb in the five years after they took part in the Wound management for Open Lower Limb Fracture (WOLLF) trial. The WOLLF trial compared standard dressings to negative pressure wound therapy (NPWT) applied at the end of the first surgical wound debridement, and patients were followed-up for 12 months. At 12 months, 170 of the original 460 participants agreed to take part in this medium-term follow-up study. Patients reported their Disability Rating Index (DRI) (0 to 100, where 100 is total disability) and health-related quality of life (HRQoL) using the EuroQol five-dimension three-level health questionnaire (EQ-5D-3L) annually by self-reported questionnaire. Further surgical interventions related to the open fracture were also recorded.Aims
Methods
The aim of this study was to investigate the relationship between the Orthopaedic Trauma Society (OTS) classification of open fractures and economic costs. Resource use was measured during the six months that followed open fractures of the lower limb in 748 adults recruited as part of two large clinical trials within the UK Major Trauma Research Network. Resource inputs were valued using unit costs drawn from primary and secondary sources. Economic costs (GBP sterling, 2017 to 2018 prices), estimated from both a NHS and Personal Social Services (PSS) perspective, were related to the degree of complexity of the open fracture based on the OTS classification.Aims
Methods
Deep surgical site infection (SSI) is common after lower limb fracture. We compared the diagnosis of deep SSI using alternative methods of data collection and examined the agreement of clinical photography and in-person clinical assessment by the Centers for Disease Control and Prevention (CDC) criteria after lower limb fracture surgery. Data from two large, UK-based multicentre randomized controlled major trauma trials investigating SSI and wound healing after surgical repair of open lower limb fractures that could not be primarily closed (UK WOLLF), and surgical incisions for fractures that were primarily closed (UK WHiST), were examined. Trial interventions were standard wound care management and negative pressure wound therapy after initial surgical debridement. Wound outcomes were collected from 30 days to six weeks. We compared the level of agreement between wound photography and clinical assessment of CDC-defined SSI. We are also assessed the level of agreement between blinded independent assessors of the photographs.Aims
Methods
The aim of the Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) was to determine the optimal treatment for adults with a bicortical undisplaced or minimally displaced fracture of the waist of the scaphoid, comparing early surgical fixation with initial cast immobilization, with immediate fixation being offered to patients with nonunion. A cost-effectiveness analysis was conducted to assess the relative merits of these forms of treatment. The differences in costs to the healthcare system and quality-adjusted life years (QALYs) of the patients over the one-year follow-up of the trial in the two treatment arms were estimated using regression analysis.Aims
Methods
The aim of this study was to assess the effect of time to surgical intervention from admission on mortality and morbidity for patients with hip fractures. MEDLINE and Embase were searched from inception to June 2020. Reference lists were manually assessed to identify additional papers. Primary comparative research studies that recruited patients aged over 60 years, with non-pathological primary proximal femoral fractures that were treated surgically, were included. Studies that did not include a group operated on within 24 hours or which reported time to surgery in calendar days were excluded. Two investigators extracted data on study characteristics, methods, and outcomes. The pre-defined primary outcome was 30-day mortality. Secondary outcomes were complications and mortality at other time points. Relative risks (RRs) with 95% confidence intervals (CIs) were aggregated and were grouped by study-level characteristics.Aims
Methods
To identify the prevalence of neuropathic pain after lower limb fracture surgery, assess associations with pain severity, quality of life and disability, and determine baseline predictors of chronic neuropathic pain at three and at six months post-injury. Secondary analysis of a UK multicentre randomized controlled trial (Wound Healing in Surgery for Trauma; WHiST) dataset including adults aged 16 years or over following surgery for lower limb major trauma. The trial recruited 1,547 participants from 24 trauma centres. Neuropathic pain was measured at three and six months using the Doleur Neuropathique Questionnaire (DN4); 701 participants provided a DN4 score at three months and 781 at six months. Overall, 933 participants provided DN4 for at least one time point. Physical disability (Disability Rating Index (DRI) 0 to 100) and health-related quality-of-life (EuroQol five-dimension five-level; EQ-5D-5L) were measured. Candidate predictors of neuropathic pain included sex, age, BMI, injury mechanism, concurrent injury, diabetes, smoking, alcohol, analgaesia use pre-injury, index surgery location, fixation type, Injury Severity Score, open injury, and wound care.Aims
Methods
The use of tourniquets in lower limb trauma surgery to control bleeding and improve the surgical field is a long established practice. In this article, we review the evidence relating to harms and benefits of tourniquet use in lower limb fracture fixation surgery and report the results of a survey on current tourniquet practice among trauma surgeons in the UK.
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
This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial. The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.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 describe a new objective classification for open fractures of the lower limb and to correlate the classification with patient-centred outcomes. The proposed classification was investigated within a cohort of adults with open fractures of the lower limb who were recruited as part of two large clinical trials within the UK Major Trauma Network. The classification was correlated with patient-reported Disability Rating Index (DRI) and EuroQol five-dimension questionnaire (EQ-5D) health-related quality of life in the year after injury, and with deep infection at 30 days, according to the Centers for Disease Control and Prevention definition of a deep surgical site infection.Aims
Methods
We conducted a systematic review and meta-analysis to compare the mortality, morbidity, and functional outcomes of cemented versus uncemented hemiarthroplasty in the treatment of intracapsular hip fractures, analyzing contemporary and non-contemporary implants separately. PubMed, Medline, EMBASE, CINAHL, and Cochrane Library were searched to 2 February 2020 for randomized controlled trials (RCTs) comparing the primary outcome, mortality, and secondary outcomes of function, quality of life, reoperation, postoperative complications, perioperative outcomes, pain, and length of hospital stay. Relative risks (RRs) and mean differences (with 95% confidence intervals (CIs)) were used as summary association measures.Aims
Methods
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
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
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
The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients. Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury.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
Hip fractures are associated with high morbidity, mortality, and costs. One strategy for improving outcomes is to incentivize hospitals to provide better quality of care. We aimed to determine whether a pay-for-performance initiative affected hip fracture outcomes in England by using Scotland, which did not participate in the scheme, as a control. We undertook an interrupted time series study with data from all patients aged more than 60 years with a hip fracture in England (2000 to 2018) using the Hospital Episode Statistics Admitted Patient Care (HES APC) data set linked to national death registrations. Difference-in-differences (DID) analysis incorporating equivalent data from the Scottish Morbidity Record was used to control for secular trends. The outcomes were 30-day and 365-day mortality, 30-day re-admission, time to operation, and acute length of stay.Aims
Materials 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 estimate economic outcomes associated with deep surgical site infection (SSI) in patients with an open fracture of the lower limb. A total of 460 patients were recruited from 24 specialist trauma hospitals in the United Kingdom Major Trauma Network. Preference-based health-related quality-of-life outcomes, assessed using the EuroQol EQ-5D-3L and the 6-Item Short-Form Health Survey questionnaire (SF-6D), and economic costs (£, 2014/2015 prices) were measured using participant-completed questionnaires over the 12 months following injury. Descriptive statistics and multivariate regression analysis were used to explore the relationship between deep SSI and health utility scores, quality-adjusted life-years (QALYs), and health and personal social service (PSS) costs.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
Meniscal allograft transplantation is undertaken to improve pain
and function in patients with a symptomatic meniscal deficient knee
compartment. While case series have shown improvements in patient
reported outcome measures (PROMs), its efficacy has not been rigorously
evaluated. This study aimed to compare PROMs in patients having
meniscal transplantation with those having personalized physiotherapy
at 12 months. A single-centre assessor-blinded, comprehensive cohort study,
incorporating a pilot randomized controlled trial (RCT) was performed
on patients with a symptomatic compartment of the knee in which
a (sub)total meniscectomy had previously been performed. They were
randomized to be treated either with a meniscal allograft transplantation
or personalized physiotherapy, and stratified for malalignment of
the limb. They entered the preference groups if they were not willing
to be randomized. The Knee injury and Osteoarthritis Outcome Score (KOOS),
International Knee Documentation Committee (IKDC) score and Lysholm
score and complications were collected at baseline and at four,
eight and 12 months following the interventions.Aims
Patients and 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
We conducted a study to determine whether radiological parameters
correlate with patient reported functional outcome, health-related
quality of life and physical measures of function in patients with
a fracture of the distal radius. The post-operative palmar tilt and ulnar variance at six weeks
and 12 months were correlated with the Patient Rated Wrist Evaluation,
Disabilities of the Arm, Shoulder and Hand, and EuroQol scores,
grip strength, pinch strength and range of movement at three, six
and 12 months for 50 patients (mean age 57 years; 26 to 85) having surgical
fixation, with either percutaneous pinning or reconstruction with
a volar plate, for a fracture of the distal radius.Aims
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
We aimed to determine whether there is evidence of improved patient
outcomes in Major Trauma Centres following the regionalisation of
trauma care in England. An observational study was undertaken using the Trauma Audit
and Research Network (TARN), Hospital Episode Statistics (HES) and
national death registrations. The outcome measures were indicators
of the quality of trauma care, such as treatment by a senior doctor
and clinical outcomes, such as mortality in hospital.Aims
Patients and Methods
The aim of this study was to inform a definitive trial which
could determine the clinical effectiveness of the X-Bolt Dynamic
Hip Plating System compared with the sliding hip screw for patients
with complex pertrochanteric fragility fractures of the femur. This was a single centre, participant blinded, randomised, standard-of-care
controlled pilot trial. Patients aged 60 years and over with AO/ASIF
A2 and A3 type femoral pertrochanteric fractures were eligible.Aims
Patients and Methods
Our aim, using English Hospital Episode Statistics data before
during and after the Distal Radius Acute Fracture Fixation Trial
(DRAFFT), was to assess whether the results of the trial affected
clinical practice. Data were grouped into six month intervals from July 2005 to
December 2014. All patient episodes in the National Health Service
involving emergency surgery for an isolated distal radial fracture
were included.Aims
Patients and Methods
In this study, we aimed to determine whether designation as a
major trauma centre (MTC) affects the quality of care for patients
with a fracture of the hip. All patients in the United Kingdom National Hip Fracture Database,
between April 2010 and December 2013, were included. The indicators
of quality that were recorded included the time to arrival on an
orthopaedic ward, to review by a geriatrician, and to operation.
The clinical outcomes were the development of a pressure sore, discharge
home, length of stay, in-hospital mortality, and re-operation within
30 days. Aims
Patients and Methods
We present an economic evaluation using data
from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare
the relative cost effectiveness of percutaneous Kirschner wire (K-wire)
fixation and volar locking-plate fixation for patients with dorsally-displaced
fractures of the distal radius. The cost effectiveness analysis (cost per quality-adjusted life
year; QALY) was derived from a multi-centre, two-arm, parallel group,
assessor-blind, randomised controlled trial which took place in
18 trauma centres in the United Kingdom. Data from 460 patients
were available for analysis, which includes both a National Health
Service cost perspective including costs of surgery, implants and
healthcare resource use over a 12-month period after surgery, and
a societal perspective, which includes the cost of time off work
and the need for additional private care. There was only a small difference in QALYs gained for patients
treated with locking-plate fixation over those treated with K-wires.
At a mean additional cost of £714 (95% confidence interval 588 to
865) per patient, locking-plate fixation presented an incremental
cost effectiveness ratio (ICER) of £89 322 per QALY within the first
12 months of treatment. Sensitivity analyses were undertaken to
assess the ICER of locking-plate fixation compared with K-wires.
These were greater than £30 000. Compared with locking-plate fixation, K-wire fixation is a ‘cost
saving’ intervention, with similar health benefits. Cite this article:
Hip fracture is a common injury associated with
high mortality, long-term disability and huge socio-economic burden.
Yet there has been relatively little research into best treatment,
and evidence that has been generated has often been criticised for
its poor quality. Here, we discuss the advances made towards overcoming
these criticisms and the future directions for hip fracture research:
how co-ordinating existing national infrastructures and use of now
established clinical research networks will likely go some way towards
overcoming the practical and financial challenges of conducting
large trials. We highlight the importance of large collaborative
pragmatic trials to inform decision/policy makers and the progress
made towards reaching a consensus on a core outcome set to facilitate data
pooling for evidence synthesis and meta-analysis. These advances and future directions are a priority in order
to establish the high-quality evidence base required for this important
group of patients. Cite this article:
We conducted an observational radiographic study
to determine the inter- and intra-observer reliability of the AO classification
of fractures of the distal radius. Plain posteroanterior and lateral
radiographs of 456 patients with an acute fracture of the distal
radius were classified by a consultant orthopaedic hand specialist
and two specialist trainees, and the k coefficient for the inter-
and intra-observer reliability of the type, group and subgroup classification
was calculated. Only the type of fracture (A, B or C) was found to provide substantial
intra-observer reliability (k type 0.65). The inclusion
of ‘group’ and ‘subgroup’ into the classification reduced the inter-observer
reliability to fair (kgroup 0.29, ksubgroup =
0.28) and the intra-observer reliability to moderate (kgroup 0.53,
ksubgroup 0.49). Disagreement was found to arise between
specific subgroups, which may be amenable to clarification. Cite this article:
The anatomy and microstructure of the menisci
allow the effective distribution of load across the knee. Meniscectomy
alters the biomechanical environment and is a potent risk factor
for osteoarthritis. Despite a trend towards meniscus-preserving
surgery, many tears are irreparable, and many repairs fail. Meniscal allograft transplantation has principally been carried
out for pain in patients who have had a meniscectomy. Numerous case
series have reported a significant improvement in patient-reported
outcomes after surgery, but randomised controlled trials have not
been undertaken. It is scientifically plausible that meniscal allograft transplantation
is protective of cartilage, but this has not been established clinically
to date. Cite this article:
Hip fracture is a global public health problem.
The National Hip Fracture Database provides a framework for service evaluation
in this group of patients in the United Kingdom, but does not collect
patient-reported outcome data and is unable to provide meaningful
data about the recovery of quality of life. We report one-year patient-reported outcomes of a prospective
cohort of patients treated at a single major trauma centre in the
United Kingdom who sustained a hip fracture between January 2012
and March 2014. There was an initial marked decline in quality of life from baseline
measured using the EuroQol 5 Dimensions score (EQ-5D). It was followed
by a significant improvement to 120 days for all patients. Although
their quality of life improved during the year after the fracture,
it was still significantly lower than before injury irrespective
of age group or cognitive impairment (mean reduction EQ-5D 0.22;
95% confidence interval (CI) 0.17 to 0.26). There was strong evidence
that quality of life was lower for patients with cognitive impairment.
There was a mean reduction in EQ-5D of 0.28 (95% CI 0.22 to 0.35)
in patients <
80 years of age. This difference was consistent
(and fixed) throughout follow-up. Quality of life does not improve
significantly during recovery from hip fracture in patients over
80 years of age (p = 0.928). Secondary measures of function showed
similar trends. Hip fracture marks a step down in the quality of life of a patient:
it accounts for approximately 0.22 disability adjusted life years
in the first year after fracture. This is equivalent to serious
neurological conditions for which extensive funding for research
and treatment is made available. Cite this article:
The extent and depth of routine health care data
are growing at an ever-increasing rate, forming huge repositories
of information. These repositories can answer a vast array of questions.
However, an understanding of the purpose of the dataset used and
the quality of the data collected are paramount to determine the
reliability of the result obtained. This Editorial describes the importance of adherence to sound
methodological principles in the reporting and publication of research
using ‘big’ data, with a suggested reporting framework for future Cite this article:
Trauma and orthopaedics is the largest of the
surgical specialties and yet attracts a disproportionately small
fraction of available national and international funding for health
research. With the burden of musculoskeletal disease increasing,
high-quality research is required to improve the evidence base for
orthopaedic practice. Using the current research landscape in the
United Kingdom as an example, but also addressing the international
perspective, we highlight the issues surrounding poor levels of
research funding in trauma and orthopaedics and indicate avenues
for improving the impact and success of surgical musculoskeletal
research. Cite this article:
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:
Cite this article:
We compared a new fixation system, the Targon
Femoral Neck (TFN) hip screw, with the current standard treatment of
cannulated screw fixation. This was a single-centre, participant-blinded,
randomised controlled trial. Patients aged 65 years and over with
either a displaced or undisplaced intracapsular fracture of the
hip were eligible. The primary outcome was the risk of revision
surgery within one year of fixation. A total of 174 participants were included in the trial. The absolute
reduction in risk of revision was of 4.7% (95% CI 14.2 to 22.5)
in favour of the TFN hip screw (chi-squared test, p = 0.741), which
was less than the pre-specified level of minimum clinically important
difference. There were no significant differences in any of the
secondary outcome measures. We found no evidence of a clinical difference in the risk of
revision surgery between the TFN hip screw and cannulated screw
fixation for patients with an intracapsular fracture of the hip. Cite this article:
The importance for observing the intention-to-treat
approach in clinical studies is explained. Cite this article:
The variation in surgical performance, both between
centres and individual surgeons, has recently been of significant
political, media and public interest. Within the United Kingdom, a
government agenda to increase accountability amongst surgeons has
led to the online publication of ‘surgeon-level’ data. Surgeons,
journalists and the public need to understand these data if they
are to be useful in driving up standards of surgical care. This
Editorial describes the use of Funnel Plots, which are the common
means by which such data are presented, and discusses how the plots
are generated. Cite this article:
Intra-operative, peri-articular injection of
local anaesthesia is an increasingly popular way of controlling
pain following total knee replacement. The evidence from this study suggests that it is safe to use
peri-articular injection in combination with auto-transfusion of
blood from peri-articular drains during knee replacement surgery.
The ideal form of fixation for displaced, extra-articular
fractures of the distal tibia remains controversial. In the UK, open
reduction and internal fixation with locking-plates and intramedullary
nailing are the two most common forms of treatment. Both techniques
provide reliable fixation but both are associated with specific
complications. There is little information regarding the functional
recovery following either procedure. We performed a randomised pilot trial to determine the functional
outcome of 24 adult patients treated with either a locking-plate
(n = 12) or an intramedullary nailing (n = 12). At six months, there
was an adjusted difference of 13 points in the Disability Rating
Index in favour of the intramedullary nail. However, this was not
statistically significant in this pilot trial (p = 0.498). A total
of seven patients required further surgery in the locking-plate
group and one in the intramedullary nail group. This study suggests that there may be clinically relevant, functional
differences in patients treated with nail
Rupture of the tendo Achillis is a common injury
with a rising incidence. Traditionally the key question following
this injury has been whether or not to operate. However a contemporary
Cochrane review highlighted that the method of rehabilitation may
also have an important contribution to the outcome. Since this review,
various early weight-bearing rehabilitation protocols have been
described. Currently evidence points to the use of early functional
rehabilitation, regardless of operative or non-operative management.
However, there is no consensus on which exact functional rehabilitation
protocol should be used. Future research should be directed towards
improving our understanding of how the different rehabilitative
components interact in the tendo Achillis as it heals.
Concerns have been reported to the United Kingdom
National Patient Safety Agency, warning that cementing the femoral component
during hip replacement surgery for fracture of the proximal femur
may increase peri-operative mortality. The National Hip Fracture Database collects demographic and outcome
data about patients with a fracture of the proximal femur from over
100 participating hospitals in the United Kingdom. We conducted
a mixed effects logistic regression analysis of this dataset to
determine whether peri-operative mortality was increased in patients
who had undergone either hemiarthroplasty or total hip replacement
using a cemented femoral component. A total of 16 496 patients from
129 hospitals were included in the analysis, which showed a small
but significant adjusted survival benefit associated with cementing
(odds ratio 0.83, 95% confidence interval 0.72 to 0.96). Other statistically
significant variables in predicting death at discharge, listed in
order of magnitude of effect, were gender, American Society of Anesthesiologists
grade, age, walking accompanied outdoors and arthroplasty. Interaction
terms between cementing and these other variables were sequentially
added to, but did not improve, the model. This study has not shown an increase in peri-operative mortality
as a result of cementing the femoral component in patients requiring
hip replacement following fracture of the proximal femur.
The poor reporting and use of statistical methods in orthopaedic papers has been widely discussed by both clinicians and statisticians. A detailed review of research published in general orthopaedic journals was undertaken to assess the quality of experimental design, statistical analysis and reporting. A representative sample of 100 papers was assessed for compliance to CONSORT and STROBE guidelines and the quality of the statistical reporting was assessed using a validated questionnaire. Overall compliance with CONSORT and STROBE guidelines in our study was 59% and 58% respectively, with very few papers fulfilling all criteria. In 37% of papers patient numbers were inadequately reported; 20% of papers introduced new statistical methods in the ‘results’ section not previously reported in the ‘methods’ section, and 23% of papers reported no measurement of error with the main outcome measure. Taken together, these issues indicate a general lack of statistical rigour and are consistent with similar reviews undertaken in a number of other scientific and clinical research disciplines. It is imperative that the orthopaedic research community strives to improve the quality of reporting; a failure to do so could seriously limit the development of future research.
The 2010 Fellows undertook a six-week journey through centres of orthopaedic excellence along the East Coast of Canada and the United States. What we learned and gained from the experience and each other is immeasurable, but five areas particularly stand out; education, research, service delivery, financial insights and professional development.
Between May 1998 and May 2007 we carried out 50 Avon patellofemoral joint replacements in 32 patients with isolated patellofemoral osteoarthritis. There were no revisions in the first five years, giving a cumulative survival of 100% for those with a minimum follow-up of five years. The mean follow-up was 5.3 years (2.1 to 10.2). The median Oxford knee score was 30.5 (interquartile range 22.25 to 42.25). In patients with bilateral replacements the median Euroqol General health score was 50 which was significantly lower than that of 75 in those with a unilateral replacement (p = 0.047). The main complication was progression of disease, which was identified radiologically in 11 knees (22%). This highlights the need for accurate selection of patients. Our findings suggest that the Avon prosthesis survives well and gives a satisfactory functional outcome in the medium term.
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%).
We performed two independent, randomised, controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis. The first trial, on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair. Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen. The second trial, on conservatively-treated patients, provided no evidence of a functional benefit from immediate weight-bearing mobilisation. However, the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate. In particular, there was no evidence of tendon lengthening or a higher re-rupture rate. We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis.
One of the factors that influence the outcome after rupture of the tendo Achillis is abnormality of gait. We prospectively assessed 14 patients and 15 normal control subjects using an in-shoe plantar pressure measurement system. There was a significant reduction in peak mean forefoot pressure in the early period of rehabilitation (p <
0.001). There was a concomitant rise in heel pressure on the injured side (p = 0.05). However, there was no difference in cadence, as determined by the duration of the terminal stance and pre-swing phases as a proportion of total stance. The forefoot pressure deficit in the group with tendon ruptures was smaller when assessed six months after the injury but was still significant (p = 0.029). Pedobarographic assessment confirms that there are marked abnormalities within the gait cycle. Rehabilitation programmes which address these abnormalities may improve outcome.
Anterior knee pain due to dysplasia of the extensor mechanism is common. We have studied 137 knees (103 patients) in order to identify a rapid and reproducible radiological feature which would indicate the need for further analysis. Overall, 67 knees (49%) had at least one radiological abnormality; 70 (51%) were considered normal. There were five cases of Dejour type-3 dysplasia of the femoral trochlea, nine of type-2 and 12 of type-1. There were 49 cases of patella alta and five of patella infera. Four knees had an abnormal lateral patellofemoral angle (patellar tilt), and in 15 knees there was more than one abnormality. Classification of trochlear dysplasia was difficult and showed poor reproducibility. This was also true for the measurement of the lateral patellofemoral angle. Patellar height was more easily measured but took time. The sulcus angle is an easily and rapidly measurable feature which was reproducible and was closely related to other features of dysplasia of the extensor mechanism. The finding of a normal sulcus angle suggested that seeking other radiological evidence of malalignment of the extensor mechanism was unlikely to reveal additional useful information. The severity of other features of dysplasia of the extensor mechanism correlated with increasing sulcus angle.
