The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. Recent guidance from The National Institute for Health and Clinical Excellence (NICE) states that research into the clinical and cost effectiveness of total hip arthroplasty (THA) as a treatment for hip fracture is a priority. We asked the question: can a trial investigating THA for hip fracture currently be delivered in the NHS? We performed a contemporaneous process evaluation that provides a context for the interpretation of the findings of WHiTE Two – a randomised study of THA for hip fracture. We developed a mixed methods approach to situate the trial centre within the context of wider United Kingdom clinical practice. We focused on fidelity, implementation, acceptability and feasibility of both the trial processes and interventions to stakeholder groups, such as healthcare providers and patients.Objectives
Methods
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
Adolescent idiopathic scoliosis affects about
3% of children. Non-operative measures are aimed at altering the natural
history to maintain the size of the curve below 40° at skeletal
maturity. The application of braces to treat spinal deformity pre-dates
the era of evidence-based medicine, and there is a paucity of irrefutable
prospective evidence in the literature to support their use and
their effectiveness has been questioned. This review considers this evidence. The weight of the evidence
is in favour of bracing over observation. The most recent literature
has moved away from addressing this question, and instead focuses
on developments in the design of braces and ways to improve compliance. Cite this article:
We conducted a meta-analysis, including randomised
controlled trials (RCTs) and cohort studies, to examine the effect
of patient-specific instruments (PSI) on radiological outcomes after
total knee replacement (TKR) including: mechanical axis alignment
and malalignment of the femoral and tibial components in the coronal,
sagittal and axial planes, at a threshold of >
3º from neutral.
Relative risks (RR) for malalignment were determined for all studies
and for RCTs and cohort studies separately. Of 325 studies initially identified, 16 met the eligibility criteria,
including eight RCTs and eight cohort studies. There was no significant
difference in the likelihood of mechanical axis malalignment with
PSI We conclude that PSI does not improve the accuracy of alignment
of the components in TKR compared with conventional instrumentation. Cite this article:
We report a systematic review and meta-analysis
of published randomised and quasi-randomised trials evaluating the
efficacy of pre-operative skin antisepsis and cleansing techniques
in reducing foot and ankle skin flora. The post-preparation culture
number (Post-PCN) was the primary outcome. The data were evaluated
using a modified version of the Cochrane Collaboration’s tool. We
identified eight trials (560 participants, 716 feet) that met the inclusion
criteria. There was a significant difference in the proportions
of Post-PCN between hallux nailfold (HNF) and toe web spaces (TWS)
sites: 0.47 Meta-analyses showed that alcoholic chlorhexidine had better
efficacy than alcoholic povidone-iodine (PI) at HNF sites (risk
difference 0.19 (95% CI 0.08 to 0.30); p = 0.0005); a two-step intervention
using PI scrub and paint (S&
P) followed by alcohol showed significantly
better efficacy over PI (S&
P) alone at TWS sites (risk difference
0.13 (95% CI 0.02 to 0.24); p = 0.0169); and a two-step intervention
using chlorhexidine scrub followed by alcohol showed significantly
better efficacy over PI (S&
P) alone at the combined (HNF with
TWS) sites (risk difference 0.27 (95% CI 0.13 to 0.40); p <
0.0001).
No significant difference was found between cleansing techniques. Cite this article:
We report the kinematic and early clinical results
of a patient- and observer-blinded randomised controlled trial in which
CT scans were used to compare potential impingement-free range of
movement (ROM) and acetabular component cover between patients treated
with either the navigated ‘femur-first’ total hip arthroplasty (THA) method
(n = 66; male/female 29/37, mean age 62.5 years; 50 to 74) or conventional
THA (n = 69; male/female 35/34, mean age 62.9 years; 50 to 75).
The Hip Osteoarthritis Outcome Score, the Harris hip score, the
Euro-Qol-5D and the Mancuso THA patient expectations score were
assessed at six weeks, six months and one year after surgery. A
total of 48 of the patients (84%) in the navigated ‘femur-first’
group and 43 (65%) in the conventional group reached all the desirable
potential ROM boundaries without prosthetic impingement for activities
of daily living (ADL) in flexion, extension, abduction, adduction
and rotation (p = 0.016). Acetabular component cover and surface
contact with the host bone were >
87% in both groups. There was
a significant difference between the navigated and the conventional
groups’ Harris hip scores six weeks after surgery (p = 0.010). There
were no significant differences with respect to any clinical outcome
at six months and one year of follow-up. The navigated ‘femur-first’
technique improves the potential ROM for ADL without prosthetic
impingement, although there was no observed clinical difference
between the two treatment groups. Cite this article:
This prospective randomised controlled trial was designed to
evaluate the outcome of both the MRI- and CT-based patient-specific
matched guides (PSG) from the same manufacturer. A total of 137 knees in 137 patients (50 men, 87 women) were
included, 67 in the MRI- and 70 in the CT-based PSG group. Their
mean age was 68.4 years (47.0 to 88.9). Outcome was expressed as
the biomechanical limb alignment (centre hip-knee-ankle: HKA-axis)
achieved post-operatively, the position of the individual components
within 3° of the pre-operatively planned alignment, correct planned
implant size and operative data (e.g. operating time and blood loss).Aims
Patients and Methods
The aim of this study was to review the role
of clinical trial networks in orthopaedic surgery. A total of two
electronic databases (MEDLINE and EMBASE) were searched from inception
to September 2013 with no language restrictions. Articles related
to randomised controlled trials (RCTs), research networks and orthopaedic
research, were identified and reviewed. The usefulness of trainee-led
research collaborations is reported and our knowledge of current
clinical trial infrastructure further supplements the review. Searching
yielded 818 titles and abstracts, of which 12 were suitable for
this review. Results are summarised and presented narratively under
the following headings: 1) identifying clinically relevant research
questions; 2) education and training; 3) conduct of multicentre
RCTs and 4) dissemination and adoption of trial results. This review
confirms growing international awareness of the important role research
networks play in supporting trials in orthopaedic surgery. Multidisciplinary
collaboration and adequate investment in trial infrastructure are crucial
for successful delivery of RCTs. Cite this article:
The outcome after total hip replacement has improved
with the development of surgical techniques, better pain management
and the introduction of enhanced recovery pathways. These pathways
require a multidisciplinary team to manage pre-operative education,
multimodal pain control and accelerated rehabilitation. The current economic
climate and restricted budgets favour brief hospitalisation while
minimising costs. This has put considerable pressure on hospitals
to combine excellent results, early functional recovery and shorter
admissions. In this review we present an evidence-based summary of some common
interventions and methods, including pre-operative patient education,
pre-emptive analgesia, local infiltration analgesia, pre-operative
nutrition, the use of pulsed electromagnetic fields, peri-operative
rehabilitation, wound dressings, different surgical techniques, minimally
invasive surgery and fast-track joint replacement units. Cite this article:
Total knee replacement (TKR) is an operation
that can be performed with or without the use of a tourniquet. Meta-analyses
of the available Level-1 studies have demonstrated that the use
of a tourniquet leads to a significant reduction in blood loss.
The opponents for use of a tourniquet cite development of complications
such as skin bruising, neurovascular injury, and metabolic disturbance
as drawbacks. Although there may certainly be reason for concern
in arteriopathic patients, there is little evidence that routine
use of a tourniquet during TKR results in any of the above complications.
The use of a tourniquet, on the other hand, provides a bloodless
field that allows the surgeon to perform the procedure with expediency
and optimal visualisation. Blood conservation has gained great importance
in recent years due to increased understanding of the problems associated
with blood transfusion, such as increased surgical site infection
(due to immunomodulation effect), increased length of hospital stay
and increased cost. Based on the authors’ understanding of the available
evidence, the routine use of a tourniquet during TKR is justified
as good surgical practice. Cite this article:
We reviewed 59 bone graft substitutes marketed
by 17 companies currently available for implantation in the United Kingdom,
with the aim of assessing the peer-reviewed literature to facilitate
informed decision-making regarding their use in clinical practice.
After critical analysis of the literature, only 22 products (37%)
had any clinical data. Norian SRS (Synthes), Vitoss (Orthovita),
Cortoss (Orthovita) and Alpha-BSM (Etex) had Level I evidence. We question
the need for so many different products, especially with limited
published clinical evidence for their efficacy, and conclude that
there is a considerable need for further prospective randomised
trials to facilitate informed decision-making with regard to the
use of current and future bone graft substitutes in clinical practice. 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:
The cause of dissatisfaction following total
knee arthroplasty (TKA) remains elusive. Much attention has been
focused on static mechanical alignment as a basis for surgical success and
optimising outcomes. More recently, research on both normal and
osteoarthritic knees, as well as kinematically aligned TKAs, has
suggested that other specific and dynamic factors may be more important
than a generic target of 0 ± 3º of a neutral axis. Consideration
of these other variables is necessary to understand ideal targets
and move beyond generic results. Cite this article:
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
Evidence -based medicine (EBM) is designed to inform clinical decision-making within all medical specialties, including orthopaedic surgery. We recently published a pilot survey of the Canadian Orthopaedic Association (COA) membership and demonstrated that the adoption of EBM principles is variable among Canadian orthopaedic surgeons. The objective of this study was to conduct a broader international survey of orthopaedic surgeons to identify characteristics of research studies perceived as being most influential in informing clinical decision-making. A 29-question electronic survey was distributed to the readership of an established orthopaedic journal with international readership. The survey aimed to analyse the influence of both extrinsic (journal quality, investigator profiles, etc.) and intrinsic characteristics (study design, sample size, etc.) of research studies in relation to their influence on practice patterns.Objectives
Materials and Methods