Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.Aims
Methods
The aim of this study was to evaluate the functional outcome in patients undergoing implant removal (IR) after fracture fixation below the level of the knee. All adult patients (18 to 75 years) undergoing IR after fracture fixation below the level of the knee between November 2014 and September 2016 were included as part of the WIFI (Wound Infections Following Implant Removal Below the Knee) trial, performed in 17 teaching hospitals and two university hospitals in The Netherlands. In this multicentre prospective cohort, the primary outcome was the difference in functional status before and after IR, measured by the Lower Extremity Functional Scale (LEFS), with a minimal clinically important difference of nine points.Aims
Patients and Methods
The primary aim of this prognostic study was to identify baseline
factors associated with physical health-related quality of life
(HRQL) in patients after a femoral neck fracture. The secondary
aims were to identify baseline factors associated with mental HRQL,
hip function, and health utility. Patients who were enrolled in the Fixation using Alternative
Implants for the Treatment of Hip Fractures (FAITH) trial completed
the 12-item Short Form Health Survey (SF-12), Western Ontario and
McMaster Universities Arthritis Index, and EuroQol 5-Dimension at
regular intervals for 24 months. We conducted multilevel mixed models
to identify factors potentially associated with HRQL. 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
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
Aims. Responsiveness to clinically important change is a key feature of any outcome measure. Throughout Europe, health-related quality of life following total knee arthroplasty (TKA) is routinely measured with EuroQol five-dimension (EQ-5D) questionnaires. The Patient-Reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10 Global Health) score is a new general heath outcome tool which is thought to offer greater responsiveness. Our aim was to compare these two tools. Patients and Methods. We accessed data from a prospective multicentre cohort study in the United Kingdom, which evaluated outcomes following TKA. The median age of the 721 patients was 69.0 years (interquartile range, 63.3 to 74.6). There was an even division of sex, and approximately half were educated to secondary school level. The preoperative EQ-5D, PROMIS-10, and Oxford Knee Scores (OKS) were available and at three, six, and 12 months postoperatively. Internal responsiveness was assessed by standardized response mean (SRM) and effect size (Cohen’s d). External responsiveness was assessed by correlating change scores of the EQ-5D and PROMIS-10, with the minimal clinically important difference (MCID) of the OKS. Receiver operating characteristic (ROC) curves were used to assess the ability of change scores to discriminate between improved and non-improved patients. Results. All measures showed significant changes between the preoperative score and the various postoperative times (p < 0.001). Most improvement occurred during the first three months, with small but significant changes between three and six months, and no further change between six and 12 months postoperatively. SRM
Complex displaced osteoporotic acetabular fractures in the elderly are associated with high levels of morbidity and mortality. Surgical options include either open reduction and internal fixation alone, or combined with total hip arthroplasty (THA). There remains a cohort of severely comorbid patients who are deemed unfit for extensive surgical reconstruction and are treated conservatively. We describe the results of a coned hemipelvis reconstruction and THA inserted via a posterior approach to the hip as the primary treatment for this severely high-risk cohort. We have prospectively monitored a series of 22 cases (21 patients) with a mean follow-up of 32 months (13 to 59).Aims
Methods
The primary aim of this study was to quantify the improvement in patient-reported outcome measures (PROMs) following total hip arthroplasty (THA), as well as the extent of any deterioration through the seven-year follow-up. The secondary aim was to identify predictors of PROM improvement and deterioration. A total of 976 patients were enrolled into a prospective, international, multicentre study. Patients completed a battery of PROMs prior to THA, at three months post-THA, and at one, three, five, and seven-years post-THA. The Harris Hip Score (HHS), the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS), the SF-36 Mental Component Summary (MCS), and the EuroQol five-dimension three-level (EQ-5D) index were the primary outcomes. Longitudinal changes in each PROM were investigated by piece-wise linear mixed effects models. Clinically significant deterioration was defined for each patient as a decrease of one half of a standard deviation (group baseline).Aims
Patients and Methods
The aim of this study was to identify predictors of return to
work (RTW) after revision lower limb arthroplasty in patients of
working age in the United Kingdom. We assessed 55 patients aged ≤ 65 years after revision total
hip arthroplasty (THA). There were 43 women and 12 men with a mean
age of 54 years (23 to 65). We also reviewed 30 patients after revision
total knee arthroplasty (TKA). There were 14 women and 16 men with
a mean age of 58 years (48 to 64). Preoperatively, age, gender,
body mass index, social deprivation, mode of failure, length of
primary implant survival, work status and nature, activity level
(University of California, Los Angeles (UCLA) score), and Oxford
Hip and Knee Scores were recorded. Postoperatively, RTW status,
Oxford Hip and Knee Scores, EuroQol-5D (EQ-5D), UCLA score, and
Work, Osteoarthritis and Joint-Replacement Questionnaire (WORQ)
scores were obtained. Univariate and multivariate analysis was performed.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
Little is known about employment following total knee arthroplasty
(TKA). This study aims to identify factors which predict return
to work following TKA in patients of working age in the United Kingdom. We prospectively assessed 289 patients (289 TKAs) aged ≤ 65 years
who underwent TKA between 2010 and 2013. There were 148 women. The
following were recorded pre-operatively: age, gender, body mass
index, social deprivation, comorbidities, indication for surgery,
work status and nature of employment, activity level as assessed by
the University of California, Los Angeles (UCLA) activity score
and Oxford Knee Score (OKS). The intention of patients to return
to work or to retire was not assessed pre-operatively. At a mean
of 3.4 years (2 to 4) post-operatively, the return to work status,
OKS, the EuroQol-5 dimensions (EQ-5D) score, UCLA activity score
and Work, Osteoarthritis and joint-Replacement (WORQ) score were
obtained. Univariate and multivariate analyses were performed.Aims
Patients &
Methods
The routine use of dual-mobility (DM) acetabular components in total hip arthroplasty (THA) may not be cost-effective, but an increasing number of patients undergoing THA have a coexisting spinal disorder, which increases the risk of postoperative instability, and these patients may benefit from DM articulations. This study seeks to examine the cost-effectiveness of DM components as an alternative to standard articulations in these patients. A decision analysis model was used to evaluate the cost-effectiveness of using DM components in patients who would be at high risk for dislocation within one year of THA. Direct and indirect costs of dislocation, incremental costs of using DM components, quality-adjusted life-year (QALY) values, and the probabilities of dislocation were derived from published data. The incremental cost-effectiveness ratio (ICER) was established with a willingness-to-pay threshold of $100 000/QALY. Sensitivity analysis was used to examine the impact of variation.Aims
Patients and Methods
The purpose of this study was to compare two different types
of metal-on-metal (MoM) bearing for total hip arthroplasty (THA):
one with a large femoral head (38 mm to 52 mm) and the other with
a conventional femoral head (28 mm or 32 mm). We compared clinical
outcome, blood metal ion levels, and the incidence of pseudotumour in
the two groups. Between December 2009 and December 2011, 62 patients underwent
MoM THA with a large femoral head (Magnum group) and 57 patients
an MoM THA with a conventional femoral head (conventional group).
Clinical outcome was assessed using the Harris Hip score, University
of California, Los Angeles (UCLA) activity score and EuroQol-5D
(EQ-5D). Blood metal ion levels were measured and MRI scans were
analyzed at a minimum of five years postoperatively.Aims
Patients and Methods
The Edinburgh Trauma Triage Clinic (TTC) streamlines outpatient
care through consultant-led ‘virtual’ triage of referrals and the
direct discharge of minor fractures from the Emergency Department.
We compared the patient outcomes for simple fractures of the radial
head, little finger metacarpal, and fifth metatarsal before and
after the implementation of the TTC. A total of 628 patients who had sustained these injuries over
a one-year period were identified. There were 337 patients in the
pre-TTC group and 289 in the post-TTC group. The Disabilities of
the Arm, Shoulder and Hand Score (QuickDASH) or Foot and Ankle Disability
Index (FADI), EuroQol-5D (EQ-5D), visual analogue scale (VAS) pain
score, satisfaction rates, and return to work/sport were assessed
six months post-injury. The development of late complications was
excluded by an electronic record evaluation at three years post-injury.
A cost analysis was performed.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:
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
