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
Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.Background
Design
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:
Subtotal or total meniscectomy in the medial or lateral compartment
of the knee results in a high risk of future osteoarthritis. Meniscal
allograft transplantation has been performed for over thirty years
with the scientifically plausible hypothesis that it functions in
a similar way to a native meniscus. It is thought that a meniscal
allograft transplant has a chondroprotective effect, reducing symptoms
and the long-term risk of osteoarthritis. However, this hypothesis has
never been tested in a high-quality study on human participants.
This study aims to address this shortfall by performing a pilot
randomised controlled trial within the context of a comprehensive
cohort study design. Patients will be randomised to receive either meniscal transplant
or a non-operative, personalised knee therapy program. MRIs will
be performed every four months for one year. The primary endpoint
is the mean change in cartilage volume in the weight-bearing area
of the knee at one year post intervention. Secondary outcome measures
include the mean change in cartilage thickness, T2 maps, patient-reported
outcome measures, health economics assessment and complications.Objectives
Methods
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:
The evidence base to inform the management of Achilles tendon
rupture is sparse. The objectives of this research were to establish
what current practice is in the United Kingdom and explore clinicians’
views on proposed further research in this area. This study was
registered with the ISRCTN (ISRCTN68273773) as part of a larger
programme of research. We report an online survey of current practice in the United
Kingdom, approved by the British Orthopaedic Foot and Ankle Society
and completed by 181 of its members. A total of ten of these respondents
were invited for a subsequent one-to-one interview to explore clinician
views on proposed further research in this area.Objectives
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:
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 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:
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 surgical community is plagued with a reputation
for both failing to engage and to deliver on clinical research.
This is in part due to the absence of a strong research culture, however
it is also due to a multitude of barriers encountered in clinical
research; particularly those involving surgical interventions. ‘Trauma’
amplifies these barriers, owing to the unplanned nature of care,
unpredictable work patterns, the emergent nature of treatment and
complexities in the consent process. This review discusses the barriers
to clinical research in surgery, with a particular emphasis on trauma.
It considers how barriers may be overcome, with the aim to facilitate
future successful clinical research. Cite this article:
To study the measurement properties of a joint specific patient
reported outcome measure, a measure of capability and a general
health-related quality of life (HRQOL) tool in a large cohort of
patients with a hip fracture. Responsiveness and associations between the Oxford Hip Score
(a hip specific measure: OHS), ICEpop CAPability (a measure of capability
in older people: ICECAP-O) and EuroQol EQ-5D (general health-related
quality of life measure: EQ-5D) were assessed using data available
from two large prospective studies. The three outcome measures were assessed
concurrently at a number of fixed follow-up time-points in a consecutive
sequence of patients, allowing direct assessment of change from
baseline, inter-measure associations and validity using a range
of statistical methods.Objectives
Methods
The importance for observing the intention-to-treat
approach in clinical studies is explained. Cite this article:
The peer review process for the evaluation of
manuscripts for publication needs to be better understood by the
orthopaedic community. Improving the degree of transparency surrounding
the review process and educating orthopaedic surgeons on how to
improve their manuscripts for submission will help improve both
the review procedure and resultant feedback, with an increase in
the quality of the subsequent publications. This article seeks to clarify
the peer review process and suggest simple ways in which the quality
of submissions can be improved to maximise publication success. Cite this article:
To conduct a pilot randomised controlled trial to evaluate the
feasibility of conducting a larger trial to evaluate the difference
in Victorian Institute of Sports Assessment-Achilles (VISA-A) scores
at six months between patients with Achilles tendinopathy treated
with a platelet-rich plasma (PRP) injection compared with an eccentric
loading programme. Two groups of patients with mid-substance Achilles tendinopathy
were randomised to receive a PRP injection or an eccentric loading
programme. A total of 20 patients were randomised, with a mean age
of 49 years (35 to 66). All outcome measures were recorded at baseline,
six weeks, three months and six months.Objectives
Methods