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
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 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
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
We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial. HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.Aims
Methods
The aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients. This was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the “Best Practice Tariff” indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients.Aims
Methods
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
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
This study reports on the medium- to long-term implant survivorship
and patient-reported outcomes for the Avon patellofemoral joint
(PFJ) arthroplasty. A total of 558 Avon PFJ arthroplasties in 431 patients, with
minimum two-year follow-up, were identified from a prospective database.
Patient-reported outcomes and implant survivorship were analyzed,
with follow-up of up to 18 years.Aims
Patients and Methods
Surgical site infection (SSI) is a common complication of surgery
with an incidence of about 1% in the United Kingdom. Sutures can
lead to the development of a SSI, as micro-organisms can colonize
the suture as it is implanted. Triclosan-coated sutures, being antimicrobical,
were developed to reduce the rate of SSI. Our aim was to assess
whether triclosan-coated sutures cause a reduction in SSIs following
arthroplasty of the hip and knee. This two-arm, parallel, double-blinded study involved 2546 patients
undergoing elective total hip (THA) and total knee arthroplasty
(TKA) at three hospitals. A total of 1323 were quasi-randomized
to a standard suture group, and 1223 being quasi-randomized to the
triclosan-coated suture group. The primary endpoint was the rate
of SSI at 30 days postoperatively.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 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
Fractures of the distal femur are an important cause of morbidity.
Their optimal management remains controversial. Contemporary implants
include angular-stable anatomical locking plates and locked intramedullary
nails (IMNs). We compared the long-term patient-reported functional
outcome of fixation of fractures of the distal femur using these
two methods of treatment. A total of 297 patients were retrospectively identified from
a State-wide trauma registry in Australia: 195 had been treated
with a locking plate and 102 with an IMN. Baseline characteristics
of the patients and their fractures were recorded. Health-related
quality-of-life, functional and radiographic outcomes were compared
using mixed effects regression models at six months and one year.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
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:
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:
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
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.
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 have carried out a prospective double-blind randomised controlled trial to compare the efficacy of a single subacromial injection of the non-steroidal anti-inflammatory drug, tenoxicam, with a single injection of methylprednisolone in patients with subacromial impingement. A total of 58 patients were randomly allocated into two groups. Group A received 40 mg of methylprednisolone and group B 20 mg of tenoxicam as a subacromial injection along with lignocaine. The Constant-Murley shoulder score was used as the primary outcome measure and the Disability of Arm, Shoulder and Hand (DASH) and the Oxford Shoulder Score (OSS) as secondary measures. Six weeks after injection the improvement in the Constant-Murley score was significantly greater in the methylprednisolone group (p = 0.003) than in the tenoxicam group. The improvement in the DASH score was greater in the steroid group and the difference was statistically significant and consistent two (p <
0.01), four (p <
0.01) and six weeks (p <
0.020) after the injection. The improvement in the OSS was consistently greater in the steroid group than in the tenoxicam group. Although the difference was statistically significant at two (p <
0.001) and four (p = 0.003) weeks after the injection, it was not at six weeks (p = 0.055). Subacromial injection of tenoxicam does not offer an equivalent outcome to subacromial injection of corticosteroid at six weeks. Corticosteroid is significantly better than tenoxicam for improving shoulder function in tendonitis of the rotator cuff after six weeks.
