Objectives. As tumours of bone and soft tissue are rare, multicentre prospective collaboration is essential for meaningful research and evidence-based advances in patient care. The aim of this study was to identify barriers and facilitators encountered in large-scale collaborative research by orthopaedic oncological surgeons involved or interested in prospective multicentre collaboration. Methods. All surgeons who were involved, or had expressed an interest, in the ongoing Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial were invited to participate in a focus group to discuss their experiences with collaborative research in this area. The discussion was digitally recorded, transcribed and anonymised. The transcript was analysed qualitatively, using an analytic approach which aims to organise the data in the language of the participants with little theoretical interpretation. Results. The 13 surgeons who participated in the discussion represented orthopaedic oncology practices from seven countries (Argentina, Brazil, Italy, Spain, Denmark, United States and Canada). Four categories and associated themes emerged from the discussion: the need for collaboration in the field of orthopaedic oncology due to the rarity of the tumours and the need for high level evidence to guide treatment; motivational factors for participating in collaborative research including establishing proof of principle, learning opportunity, answering a relevant research question and being part of a collaborative research community; barriers to participation including
The aim of this systematic review and meta-analysis was to gather epidemiological information on selected musculoskeletal injuries and to provide pooled injury-specific incidence rates. PubMed (National Library of Medicine) and Scopus (Elsevier) databases were searched. Articles were eligible for inclusion if they reported incidence rate (or count with population at risk), contained data on adult population, and were written in English language. The number of cases and population at risk were collected, and the pooled incidence rates (per 100,000 person-years) with 95% confidence intervals (CIs) were calculated by using either a fixed or random effects model.Aims
Methods
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
To investigate the efficacy of ethylenediaminetetraacetic acid-normal saline (EDTA-NS) in dispersing biofilms and reducing bacterial infections. EDTA-NS solutions were irrigated at different durations (1, 5, 10, and 30 minutes) and concentrations (1, 2, 5, 10, and 50 mM) to disrupt Aims
Methods
To evaluate if union of clavicle fractures can be predicted at six weeks post-injury by the presence of bridging callus on ultrasound. Adult patients managed nonoperatively with a displaced mid-shaft clavicle were recruited prospectively. Ultrasound evaluation of the fracture was undertaken to determine if sonographic bridging callus was present. Clinical risk factors at six weeks were used to stratify patients at high risk of nonunion with a combination of Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) ≥ 40, fracture movement on examination, or absence of callus on radiograph.Aims
Methods
This feasibility study investigates the utilization and cost of health resources related to formal and informal care, home adaptations, and physiotherapy among patients aged 60 years and above after hip fracture from a multicentre cohort study (World Hip Trauma Evaluation (WHiTE)) in the UK. A questionnaire containing health resource use was completed at baseline and four months post-injury by patients or their carer. Completion rate and mean cost of each health resource item were assessed and sensitivity analysis was performed to derive a conservative estimate of the informal care cost. All costs are presented in 2017/18 pound sterling.Aims
Methods
Bone is one of the most highly adaptive tissues in the body, possessing the capability to alter its morphology and function in response to stimuli in its surrounding environment. The ability of bone to sense and convert external mechanical stimuli into a biochemical response, which ultimately alters the phenotype and function of the cell, is described as mechanotransduction. This review aims to describe the fundamental physiology and biomechanisms that occur to induce osteogenic adaptation of a cell following application of a physical stimulus. Considerable developments have been made in recent years in our understanding of how cells orchestrate this complex interplay of processes, and have become the focus of research in osteogenesis. We will discuss current areas of preclinical and clinical research exploring the harnessing of mechanotransductive properties of cells and applying them therapeutically, both in the context of fracture healing and de novo bone formation in situations such as nonunion. Cite this article:
To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice. A questionnaire was piloted with six orthopaedic surgeons using a ‘think aloud’ process. The final questionnaire contained 29 items and was distributed online to surgeon members of the British Orthopaedic Association and British Elbow and Shoulder Society. Descriptive statistics summarised the sample characteristics and fracture treatment of respondents overall, and grouped them by whether they changed practice based on PROFHER trial findings. Free-text responses were analysed qualitatively for emerging themes using Framework Analysis principles.Objectives
Methods
The primary purpose of this meta-analysis was to determine whether statin usage could reduce the risk of glucocorticoid-related osteonecrosis in animal models. A systematic literature search up to May 2015 was carried out using the PubMed, Ovid, EBM reviews, ISI Web of Science, EBSCO, CBM, CNKI databases with the term and boolean operators: statins and osteonecrosis in all fields. Risk ratio (RR), as the risk estimate of specific outcome, was calculated along with 95% confidence intervals (CI). The methodological quality of individual studies was assessed using a quantitative tool based on the updated Stroke Therapy Academic Industry Roundtable (STAIR) recommendations.Objectives
Methods
“Virtual fracture clinics” have been reported as a safe and effective alternative to the traditional fracture clinic. Robust protocols are used to identify cases that do not require further review, with the remainder triaged to the most appropriate subspecialist at the optimum time for review. The objective of this study was to perform a “top-down” analysis of the cost effectiveness of this virtual fracture clinic pathway. National Health Service financial returns relating to our institution were examined for the time period 2009 to 2014 which spanned the service redesign.Objectives
Methods
To assess the responsiveness and ceiling/floor effects of the Forgotten Joint Score -12 and to compare these with that of the more widely used Oxford Hip Score (OHS) in patients six and 12 months after primary total hip arthroplasty. We prospectively collected data at six and 12 months following total hip arthroplasty from 193 patients undergoing surgery at a single centre. Ceiling effects are outlined with frequencies for patients obtaining the lowest or highest possible score. Change over time from six months to 12 months post-surgery is reported as effect size (Cohen’s d).Objectives
Methods
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
Despite the fact that research fraud and misconduct are under scrutiny in the field of orthopaedic research, little systematic work has been done to uncover and characterise the underlying reasons for academic retractions in this field. The purpose of this study was to determine the rate of retractions and identify the reasons for retracted publications in the orthopaedic literature. Two reviewers independently searched MEDLINE, EMBASE, and the Cochrane Library (1995 to current) using MeSH keyword headings and the ‘retracted’ filter. We also searched an independent website that reports and archives retracted scientific publications (Objectives
Methods
The monitoring of fracture healing is a complex process. Typically, successive radiographs are performed and an emerging calcification of the fracture area is evaluated. The aim of this study was to investigate whether different bone healing patterns can be distinguished using a telemetric instrumented femoral internal plate fixator. An electronic telemetric system was developed to assess bone healing mechanically. The system consists of a telemetry module which is applied to an internal locking plate fixator, an external reader device, a sensor for measuring externally applied load and a laptop computer with processing software. By correlation between externally applied load and load measured in the implant, the elasticity of the osteosynthesis is calculated. The elasticity decreases with ongoing consolidation of a fracture or nonunion and is an appropriate parameter for the course of bone healing. At our centre, clinical application has been performed in 56 patients suffering nonunion or fracture of the femur.Objectives
Materials 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:
Femoroacetabular Junction Impingement (FAI) describes abnormalities
in the shape of the femoral head–neck junction, or abnormalities
in the orientation of the acetabulum. In the short term, FAI can
give rise to pain and disability, and in the long-term it significantly increases
the risk of developing osteoarthritis. The Femoroacetabular Impingement
Trial (FAIT) aims to determine whether operative or non-operative
intervention is more effective at improving symptoms and preventing
the development and progression of osteoarthritis. FAIT is a multicentre superiority parallel two-arm randomised
controlled trial comparing physiotherapy and activity modification
with arthroscopic surgery for the treatment of symptomatic FAI.
Patients aged 18 to 60 with clinical and radiological evidence of
FAI are eligible. Principal exclusion criteria include previous
surgery to the index hip, established osteoarthritis (Kellgren–Lawrence
≥ 2), hip dysplasia (centre-edge angle <
20°), and completion
of a physiotherapy programme targeting FAI within the previous 12
months. Recruitment will take place over 24 months and 120 patients
will be randomised in a 1:1 ratio and followed up for three years.
The two primary outcome measures are change in hip outcome score
eight months post-randomisation (approximately six-months post-intervention
initiation) and change in radiographic minimum joint space width
38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Aims
Methods
The National Institute for Health and Clinical
Excellence (NICE) has thus far relied on historical data and predominantly
industry-sponsored trials to provide evidence for venous thromboembolic
(VTE) prophylaxis in joint replacement patients. We argue that the
NICE guidelines may be reliant on assumptions that are in need of
revision. Following the publication of large scale, independent
observational studies showing little difference between low-molecular-weight
heparins and aspirin, and recent changes to the guidance provided
by other international bodies, should NICE reconsider their recommendations? Cite this article:
This protocol describes a pragmatic multicentre
randomised controlled trial (RCT) to assess the clinical and cost
effectiveness of arthroscopic and open surgery in the management
of rotator cuff tears. This trial began in 2007 and was modified
in 2010, with the removal of a non-operative arm due to high rates
of early crossover to surgery. Cite this article:
A patient-centred approach, usually achieved through shared decision
making, has the potential to help improve decision making around
knee arthroplasty surgery. However, such an approach requires an
understanding of the factors involved in patient decision making.
This review’s objective is to systematically examine the qualitative literature
surrounding patients’ decision making in knee arthroplasty. A systematic literature review using Medline and Embase was conducted
to identify qualitative studies that examined patients’ decision
making around knee arthroplasty. An aggregated account of what is
known about patients’ decision making in knee arthroplasties is
provided.Objectives
Methods
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 are entering a new era with governmental bodies
taking an increasingly guiding role, gaining control of registries,
demanding direct access with release of open public information
for quality comparisons between hospitals. This review is written
by physicians and scientists who have worked with the Swedish Knee
Arthroplasty Register (SKAR) periodically since it began. It reviews
the history of the register and describes the methods used and lessons
learned. Cite this article:
Total hip replacement causes a short-term increase
in the risk of mortality. It is important to quantify this and to identify
modifiable risk factors so that the risk of post-operative mortality
can be minimised. We performed a systematic review and critical
evaluation of the current literature on the topic. We identified
32 studies published over the last 10 years which provide either
30-day or 90-day mortality data. We estimate the pooled incidence
of mortality during the first 30 and 90 days following hip replacement
to be 0.30% (95% CI 0.22 to 0.38) and 0.65% (95% CI 0.50 to 0.81),
respectively. We found strong evidence of a temporal trend towards
reducing mortality rates despite increasingly co-morbid patients.
The risk factors for early mortality most commonly identified are
increasing age, male gender and co-morbid conditions, particularly
cardiovascular disease. Cardiovascular complications appear to have
overtaken fatal pulmonary emboli as the leading cause of death after
hip replacement. 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:
Osteoporosis and abnormal bone metabolism may prove to be significant
factors influencing the outcome of arthroplasty surgery, predisposing
to complications of aseptic loosening and peri-prosthetic fracture.
We aimed to investigate baseline bone mineral density (BMD) and
bone turnover in patients about to undergo arthroplasty of the hip
and knee. We prospectively measured bone mineral density of the hip and
lumbar spine using dual-energy X-ray absorptiometry (DEXA) scans
in a cohort of 194 patients awaiting hip or knee arthroplasty. We
also assessed bone turnover using urinary deoxypyridinoline (DPD),
a type I collagen crosslink, normalised to creatinine.Aims
Methods
The number of surgical procedures performed each year to treat
femoroacetabular impingement (FAI) continues to rise. Although there
is evidence that surgery can improve symptoms in the short-term,
there is no evidence that it slows the development of osteoarthritis
(OA). We performed a feasibility study to determine whether patient
and surgeon opinion was permissive for a Randomised Controlled Trial
(RCT) comparing operative with non-operative treatment for FAI. Surgeon opinion was obtained using validated questionnaires at
a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely
performed FAI surgery) and patient opinion was obtained from clinical
patients with a new diagnosis of FAI (n = 31).Objectives
Methods
Orthopaedic surgeons use stems in revision knee surgery to obtain
stability when metaphyseal bone is missing. No consensus exists
regarding stem size or method of fixation. This A custom test rig using differential variable reluctance transducers
(DVRTs) was developed to record all translational and rotational
motions at the bone–implant interface. Composite femurs were used.
These were secured to permit variation in flexion angle from 0°
to 90°. Cyclic loads were applied through a tibial component based
on three peaks corresponding to 0°, 10° and 20° flexion from a normal
walking cycle. Three different femoral components were investigated
in this study for cementless and cemented interface conditions.Objectives
Methods
