Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.
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:
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 February 2014 Hip &
Pelvis Roundup360 looks at: length of stay; cementless metaphyseal fixation; mortality trends in over 400,000 total hip replacements; antibiotics in hip fracture surgery; blood supply to the femoral head after dislocation; resurfacing and THR in metal-on-metal replacement; diabetes and hip replacement; bone remodelling over two decades following hip replacement; and whether bisphosphonates affect acetabular fixation.
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:
Hip replacement is a very successful operation and the outcome is usually excellent. There are recognised complications that seem increasingly to give rise to litigation. This paper briefly examines some common scenarios where litigation may be pursued against hip surgeons. With appropriate record keeping, consenting and surgical care, the claim can be successfully defended if not avoided. We hope this short summary will help to highlight some common pitfalls. There is extensive literature available for detailed study.
We evaluated the quality of guidelines on thromboprophylaxis
in orthopaedic surgery by examining how they adhere to validated
methodological standards in their development. A structured review
was performed for guidelines that were published between January
2005 and April 2013 in medical journals or on the Internet. A pre-defined
computerised search was used in MEDLINE, Scopus and Google to identify
the guidelines. The AGREE II assessment tool was used to evaluate
the quality of the guidelines in the study. Seven international and national guidelines were identified.
The overall methodological quality of the individual guidelines
was good. ‘Scope and Purpose’ (median score 98% interquartile range
(IQR)) 86% to 98%) and ‘Clarity of Presentation’ (median score 90%,
IQR 90% to 95%) were the two domains that received the highest scores. ‘Applicability’
(median score 68%, IQR 45% to 75%) and ‘Editorial Independence’
(median score 71%, IQR 68% to 75%) had the lowest scores. These findings reveal that although the overall methodological
quality of guidelines on thromboprophylaxis in orthopaedic surgery
is good, domains within their development, such as ‘Applicability’
and ‘Editorial Independence’, need to be improved. Application of
the AGREE II instrument by the authors of guidelines may improve
the quality of future guidelines and provide increased focus on
aspects of methodology used in their development that are not robust. Cite this article: Bone Joint J 2014;96-B:19–23.
Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.
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 October 2013 Knee Roundup360 looks at: Make it easy, release the MCL; Do patients remember clinical information in day surgery?; Osteoarthritis and arthroscopy?; How best to double your bundles; When to operate for infection; Cementless unicompartment knee replacement?; Tibial tubercle-trochlear groove confusion; Tarts, cherries and osteoarthritis
The August 2013 Research Roundup360 looks at: passive smoking and bone substitutes; platelet-rich plasma and osteogenesis; plantar fasciitis and platelet-rich plasma: a match made in heaven?; MRSA decolonisation decreases infection rates; gums, bisphosphonates and orthopaedics; PRAISE and partner violence; blunt impact and post-traumatic OA; and IDEAL research and implants
This editorial examines the influence of the National Institute for Clinical Excellence (NICE) on the conduct of orthopaedic surgery. It proffers criticism and suggests ways of improvement.
Thromboprophylaxis remains a controversial subject. A vast amount of epidemiological and trial data about venous thromboembolism has been published over the past 40 years. These data have been distilled and synthesised into guidelines designed to help the practitioner translate this extensive research into ‘evidence-based’ advice. Guidelines should, in theory, benefit patient care by ensuring that every patient routinely receives the best prophylaxis; without guidelines, it is argued, patients may fail to receive treatment or be exposed to protocols which are ineffective, dangerous or expensive. Guidelines, however, have not been welcomed or applied universally. In the United States, orthopaedic surgeons have published their concerns about the thromboprophylaxis guidelines prepared by the American College of Chest Physicians. In Britain, controversy persists with many surgeons unconvinced of the risk/benefit, cost/benefit or practicality of thromboprophylaxis. The extended remit of the recent National Institute of Clinical Excellence thromboprophylaxis guidelines has been challenged. The reasons for this disquiet are addressed in this paper and particular emphasis is placed on how clinically-acceptable guidelines could be developed and applied.
Hip implant retrieval analysis is the most important
source of insight into the performance of new materials and designs
of hip arthroplasties. Even the most rigorous
In Canada, Dupuytren's contracture is managed
with partial fasciectomy or percutaneous needle aponeurotomy (PNA).
Injectable collagenase will soon be available. The optimal management
of Dupuytren’s contracture is controversial and trade-offs exist
between the different methods. Using a cost-utility analysis approach,
our aim was to identify the most cost-effective form of treatment
for managing Dupuytren’s contracture it and the threshold at which
collagenase is cost-effective. We developed an expected-value decision
analysis model for Dupuytren’s contracture affecting a single finger,
comparing the cost-effectiveness of fasciectomy, aponeurotomy and collagenase
from a societal perspective. Cost-effectiveness, one-way sensitivity
and variability analyses were performed using standard thresholds
for cost effective treatment ($50 000 to $100 000/QALY gained).
Percutaneous needle aponeurotomy was the preferred strategy for
managing contractures affecting a single finger. The cost-effectiveness
of primary aponeurotomy improved when repeated to treat recurrence.
Fasciectomy was not cost-effective. Collagenase was cost-effective
relative to and preferred over aponeurotomy at $875 and $470 per
course of treatment, respectively. In summary, our model supports the trend towards non-surgical
interventions for managing Dupuytren’s contracture affecting a single
finger. Injectable collagenase will only be feasible in our publicly
funded healthcare system if it costs significantly less than current
United States pricing. Cite this article: