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
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
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. Controversy exists regarding
the optimal treatment for independent patients with displaced intracapsular fractures
of the proximal femur. The recognised alternatives are hemiarthroplasty
and total hip replacement. At present there is no established standard
of care, with both types of arthroplasty being used in many centres.
The principal advantages of total hip replacement are a functional
benefit over hemiarthroplasty and a reduced risk of revision surgery.
The principal criticism is the increased risk of dislocation. We
believe that an alternative acetabular component may reduce the
risk of dislocation but still provide the functional benefit of
total hip replacement in these patients. We therefore propose to
investigate the dislocation risk of a dual-mobility acetabular component
compared with standard polyethylene component in total hip replacement
for independent patients with displaced intracapsular fractures
of the proximal femur within the framework of the larger WHiTE (Warwick
Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article:
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. Controversy exists regarding
the optimal treatment for patients with unstable trochanteric proximal
femoral fractures. The recognised treatment alternatives are extramedullary
fixation usually with a sliding hip screw and intramedullary fixation
with a cephalomedullary nail. Current evidence suggests that best
results and lowest complication rates occur using a sliding hip screw.
Complications in these difficult fractures are relatively common
regardless of type of treatment. We believe that a novel device,
the X-Bolt dynamic plating system, may offer superior fixation over
a sliding hip screw with lower reoperation risk and better function.
We therefore propose to investigate the clinical effectiveness of
the X-bolt dynamic plating system compared with standard sliding
hip screw fixation within the framework of a the larger WHiTE (Warwick
Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article:
We aimed to determine the effect of surgical approach on the
histology of the femoral head following resurfacing of the hip. We performed a histological assessment of the bone under the
femoral component taken from retrieval specimens of patients having
revision surgery following resurfacing of the hip. We compared the
number of empty lacunae in specimens from patients who had originally
had a posterior surgical approach with the number in patients having alternative
surgical approaches.Objectives
Methods
Autologous bone graft has been used in the treatment of complex bone defects for more than a century. Morbidity associated with the harvest of this bone graft has led orthopaedic surgeons to seek alternative therapies in the treatment of long bone non-unions. The aim of this study was to determine whether the use of demineralised bone matrix as a bone healing adjunct improves clinical outcomes in adult patients with long bone non-union. A systematic search was carried out of the peer-reviewed English language literature to identify all relevant studies. The search strategy returned a total of 47 studies. Five of these studies were relevant to the research question. The studies were critically assessed and where appropriate combined in a meta-analysis. 4 non-comparative studies and one comparative study were reviewed. An overall estimate of the rate of union for the five studies was 86% (95%CI: 71–94%). The one comparative study demonstrated the relative risk (RR) of healing was not significantly better than in patients treated with autologous bone graft; RR=1.03 (95%CI 0.96–1.12). There are limited data to support the use of demineralised bone matrix in the treatment of long bone non-union. Demineralised bone matrix is likely to be similarly effective to other treatments in the management of non-union. This study confirms the clinical and ethical requirements to proceed with a randomised controlled trial to test the effectiveness of this intervention.
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. The National Hip Fracture
Audit currently provides a framework for service evaluation. This
evaluation is based upon the assessment of process rather than assessment
of patient-centred outcome and therefore it fails to provide meaningful
data regarding the clinical effectiveness of treatments. This study
aims to capture data from the cohort of patients who present with
a fracture of the proximal femur at a single United Kingdom Major
Trauma Centre. Patient-centred outcomes will be recorded and provide
a baseline cohort within which to test the clinical effectiveness
of experimental interventions.
There is an ever increasing demand for Randomised Controlled Trials (RCTs) in Trauma and Orthopaedic Surgery. Patient recruitment is often challenging. Among other factors, individual surgeon's preference is often quoted as a major obstacle. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution, but could not help in everyday running of a trial. We wanted to develop a new trial eligibility assessment tool using the Collective Equipoise Principle. We developed an online system that quantifies collective uncertainty among a group of surgeons for an individual clinical case in real time. This data was collected for patients in the UK Heel Fracture Trial (UK HeFT) as an independent research project. Both patients who agreed or not to take part in the trial were approached in six weeks follow up clinic to avoid interference with clinical course. For those who agreed, anonymous clinical data together with images (Xrays and CT) was published on a secure on line forum and registered surgeons were alerted via email and SMS. Surgeons submitted their opinion instantly via specially designed interactive voting scale. 80:20 ethical uncertainty distribution limit was applied using Subjective Logic to calculate an Uncertainty Index (UnIx) for every patient. This approach was evaluated as an eligibility assessment tool for RCTs.Introduction
Methods
This study is a mid-term follow up of an original series of 51 babies treated with a modified Ponseti technique for idiopathic congenital talipes equinovarus using below-knee Softcast (easier to remove and hygienic)1 to determine whether this method is as effective as traditional above-knee plastering. 51 consecutive babies were treated (April 2003-May 2007) and serial Pirani scores were recorded. Dennis Browne Boots (DBB) were applied when correction was achieved and an Achilles tenotomy was performed if necessary to complete the correction. DBB were worn fulltime for 3 months and at night for 3.5 years. Of the original 51, 3 were lost to follow up and 3 were diagnosed with a neuromuscular condition and excluded. 45 patients, 34 boys and 11 girls were followed up for a mean of 55.3 months (range 36–85 months). Mean age at presentation was 16 days with a median Pirani score of 6.0 (5.5, 60). 75.7% required an Achilles tenotomy before DBB. Median Pirani score at tenotomy was 2.5 (2.0, 2.5). Time to boots (weeks) was mean 5.0 (4.2, 6.0) in the non-tenotomy group and 10.7 (9.8, 11.8) in the tenotomy group. 2 patients had residual deformity after plastering requiring surgery and there were 6 recurrences requiring surgery (4 tibialis anterior tendon transfers and 2 open releases). There appears to be a greater risk of operative intervention for girls and non-compliance with DBB. The estimate of 5-year (60 month) survival without surgery was 85% (96% CI; 70,99%).Methods
Results
To study the vascularity and bone metabolism of the femoral head/neck
following hip resurfacing arthroplasty, and to use these results
to compare the posterior and the trochanteric-flip approaches. In our previous work, we reported changes to intra-operative
blood flow during hip resurfacing arthroplasty comparing two surgical
approaches. In this study, we report the vascularity and the metabolic
bone function in the proximal femur in these same patients at one
year after the surgery. Vascularity and bone function was assessed
using scintigraphic techniques. Of the 13 patients who agreed to
take part, eight had their arthroplasty through a posterior approach
and five through a trochanteric-flip approach.Objectives
Methods
A two sample t-test demonstrated cobalt and chromium ion levels were significantly higher in patients with abnormalities on USS (p=0.038, p=0.05 respectively), patients with normal USS were more likely to have a retroverted femoral component (p=0.01).
