The maintenance of quality and integrity in clinical
and basic science research depends upon
The
Aims. Preprint servers allow authors to publish full-text manuscripts or interim findings prior to undergoing
Aims. The use of biologics in the treatment of musculoskeletal injuries in Olympic and professional athletes appears to be increasing. There are no studies which currently map the extent, range, and nature of existing literature concerning the use and efficacy of such therapies in this arena. The objective of this scoping review is to map the available evidence regarding the use of biologics in the treatment of musculoskeletal injuries in Olympic and professional sport. Methods. Best-practice methodological frameworks suggested by Arksey and O’Malley, Levac et al, and the Joanna Briggs Institute will be used. This scoping review will aim to firstly map the current extent, range, and nature of evidence for biologic strategies to treat injuries in professional and Olympic sport; secondly, to summarize and disseminate existing research findings; and thirdly, to identify gaps in existing literature. A three-step search strategy will identify
Aims. Aseptic loosening is the most common cause of failure following cemented total knee arthroplasty (TKA), and has been linked to poor cementation technique. We aimed to develop a consensus on the optimal technique for component cementation in TKA. Methods. A UK-based, three-round, online modified Delphi Expert Consensus Study was completed focusing on cementation technique in TKA. Experts were identified as having a minimum of five years’ consultant experience in the NHS and fulfilling any one of the following criteria: a ‘high volume’ knee arthroplasty practice (> 150 TKAs per annum) as identified from the National joint Registry of England, Wales, Northern Ireland and the Isle of Man; a senior author of at least five
The OpenAI chatbot ChatGPT is an artificial intelligence (AI) application that uses state-of-the-art language processing AI. It can perform a vast number of tasks, from writing poetry and explaining complex quantum mechanics, to translating language and writing research articles with a human-like understanding and legitimacy. Since its initial release to the public in November 2022, ChatGPT has garnered considerable attention due to its ability to mimic the patterns of human language, and it has attracted billion-dollar investments from Microsoft and PricewaterhouseCoopers. The scope of ChatGPT and other large language models appears infinite, but there are several important limitations. This editorial provides an introduction to the basic functionality of ChatGPT and other large language models, their current applications and limitations, and the associated implications for clinical practice and research. Cite this article:
Lateral femoral cutaneous nerve (LFCN) injury is a potential complication after the direct anterior approach for total hip arthroplasty (DAA-THA). The aim of this study was to determine how the location of the fasciotomy in DAA-THA affects LFCN injury. In this trial, 134 patients were randomized into a lateral fasciotomy (n = 67) or a conventional fasciotomy (n = 67) group. This study was a dual-centre, double-blind, prospective randomized controlled two-arm trial with parallel group design and a 1:1 allocation ratio. The primary endpoint was the presence of LFCN injury, which was determined by the presence of numbness, decreased sensation, tingling, jolt-like sensation, or pain over the lateral aspect of the thigh, excluding the surgical scar, using a patient-based questionnaire. The secondary endpoints were patient-reported outcome measures (PROMs) using the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ), and the Forgotten Joint Score-12 (FJS-12). Assessments were obtained three months after surgery.Aims
Methods
The conventionally described mechanism of distal biceps tendon rupture (DBTR) is of a ‘considerable extension force suddenly applied to a resisting, actively flexed forearm’. This has been commonly paraphrased as an ‘eccentric contracture to a flexed elbow’. Both definitions have been frequently used in the literature with little objective analysis or citation. The aim of the present study was to use video footage of real time distal biceps ruptures to revisit and objectively define the mechanism of injury. An online search identified 61 videos reporting a DBTR. Videos were independently reviewed by three surgeons to assess forearm rotation, elbow flexion, shoulder position, and type of muscle contraction being exerted at the time of rupture. Prospective data on mechanism of injury and arm position was also collected concurrently for 22 consecutive patients diagnosed with an acute DBTR in order to corroborate the video analysis.Aims
Methods
Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon. SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.Aims
Methods
Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.Aims
Methods
To identify the minimum set of outcomes that should be collected in clinical practice and reported in research related to the care of children with idiopathic congenital talipes equinovarus (CTEV). A list of outcome measurement tools (OMTs) was obtained from the literature through a systematic review. Further outcomes were collected from patients and families through a questionnaire and interview process. The combined list, as well as the appropriate follow-up timepoint, was rated for importance in a two-round Delphi process that included an international group of orthopaedic surgeons, physiotherapists, nurse practitioners, patients, and families. Outcomes that reached no consensus during the Delphi process were further discussed and scored for inclusion/exclusion in a final consensus meeting involving international stakeholder representatives of practitioners, families, and patient charities.Aims
Methods
Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called ‘stem cell’ preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers. Cite this article:
The aim of the British Association for Surgery of the Knee (BASK) Meniscal Consensus Project was to develop an evidence-based treatment guideline for patients with meniscal lesions of the knee. A formal consensus process was undertaken applying nominal group, Delphi, and appropriateness methods. Consensus was first reached on the terminology relating to the definition, investigation, and classification of meniscal lesions. A series of simulated clinical scenarios was then created and the appropriateness of arthroscopic meniscal surgery or nonoperative treatment in each scenario was rated by the group. The process was informed throughout by the latest published, and previously unpublished, clinical and epidemiological evidence. Scenarios were then grouped together based upon the similarity of clinical features and ratings to form the guideline for treatment. Feedback on the draft guideline was sought from the entire membership of BASK before final revisions and approval by the consensus group.Aims
Materials and Methods
In 2013, we introduced a specialized, centralized, and interdisciplinary team in our institution that applied a standardized diagnostic and treatment algorithm for the management of prosthetic joint infections (PJIs). The hypothesis for this study was that the outcome of treatment would be improved using this approach. In a retrospective analysis with a standard postoperative follow-up, 95 patients with a PJI of the hip and knee who were treated with a two-stage exchange between 2013 and 2017 formed the study group. A historical cohort of 86 patients treated between 2009 and 2011 not according to the standardized protocol served as a control group. The success of treatment was defined according to the Delphi criteria in a two-year follow-up.Aims
Patients and Methods
Studying the indications for revision total hip arthroplasty (THA) may enable surgeons to change their practice during the initial procedure, thereby reducing the need for revision surgery. The aim of this study was to identify and describe the potentially avoidable indications for revision THA within five years of the initial procedure. A retrospective review of 117 patients (73 women, 44 men; mean age 61.5 years (27 to 88)) who met the inclusion criteria was conducted. Three adult reconstruction surgeons independently reviewed the radiographs and medical records, and they classified the revision THAs into two categories: potentially avoidable and unavoidable. Baseline demographics, perioperative details, and quality outcomes up to the last follow-up were recorded.Aims
Patients and Methods
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:
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
We describe the impact of a targeted performance
improvement programme and the associated performance improvement
interventions, on mortality rates, error rates and process of care
for haemodynamically unstable patients with pelvic fractures. Clinical
care and performance improvement data for 185 adult patients with exsanguinating
pelvic trauma presenting to a United Kingdom Major Trauma Centre
between January 2007 and January 2011 were analysed with univariate
and multivariate regression and compared with National data. In
total 62 patients (34%) died from their injuries and opportunities
for improved care were identified in one third of deaths. Three major interventions were introduced during the study period
in response to the findings. These were a massive haemorrhage protocol,
a decision-making algorithm and employment of specialist pelvic
orthopaedic surgeons. Interventions which improved performance were
associated with an annual reduction in mortality (odds ratio 0.64
(95% confidence interval (CI) 0.44 to 0.93), p = 0.02), a reduction
in error rates (p = 0.024) and significant improvements in the targeted
processes of care. Exsanguinating patients with pelvic trauma are
complex to manage and are associated with high mortality rates;
implementation of a targeted performance improvement programme achieved
sustained improvements in mortality, error rates and trauma care
in this group of severely injured patients. 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:
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
The August 2014 Research Roundup360 looks at: Antibiotic loaded ceramic of use in osteomyelitis; fibronectin implicated in cartilage degeneration; Zinc Chloride accelerates fracture healing in rats; advertisements and false claims; Net Promoter Score: substance or rhetoric?; aspirin for venous thromboembolism prophylaxis and dissection, stress and the soul.
Wear debris released from bearing surfaces has been shown to
provoke negative immune responses in the recipient. Excessive wear
has been linked to early failure of prostheses. Analysis using coordinate
measuring machines (CMMs) can provide estimates of total volumetric
material loss of explanted prostheses and can help to understand
device failure. The accuracy of volumetric testing has been debated,
with some investigators stating that only protocols involving hundreds
of thousands of measurement points are sufficient. We looked to
examine this assumption and to apply the findings to the clinical
arena. We examined the effects on the calculated material loss from
a ceramic femoral head when different CMM scanning parameters were
used. Calculated wear volumes were compared with gold standard gravimetric
tests in a blinded study. Objectives
Methods
The February 2013 Wrist &
Hand Roundup360 looks at: to splint or not to splint; salvage of the unsalvageable; a close shave for malunions; a classic approach to malunion; diabetic carpal tunnel; capsulodesis; a wrist from a fibula; thumb-based osteoarthritis - a further opinion from the Editor-in-Chief.
In 2006, approximately 1.3 million peer-reviewed scientific articles were published, aided by a large rise in the number of available scientific journals from 16 000 in 2001 to 23 750 by 2006. Is this evidence of an explosion in scientific knowledge or just the accumulation of wasteful publications and junk science? Data show that only 45% of the articles published in the 4500 top scientific journals are cited within the first five years of publication, a figure that is dropping steadily. Only 42% receive more than one citation. For better or for worse, “Publish or Perish” appears here to stay as the number of published papers becomes the basis for selection to academic positions, for tenure and promotions, a criterion for the awarding of grants and also the source of funding for salaries. The high pressure to publish has, however, ushered in an era where scientists are increasingly conducting and publishing data from research performed with ‘questionable research practices’ or even committing outright fraud. The few cases which are reported will in fact be the tip of an iceberg and the scientific community needs to be vigilant against this corruption of science.
The poor reporting and use of statistical methods in orthopaedic papers has been widely discussed by both clinicians and statisticians. A detailed review of research published in general orthopaedic journals was undertaken to assess the quality of experimental design, statistical analysis and reporting. A representative sample of 100 papers was assessed for compliance to CONSORT and STROBE guidelines and the quality of the statistical reporting was assessed using a validated questionnaire. Overall compliance with CONSORT and STROBE guidelines in our study was 59% and 58% respectively, with very few papers fulfilling all criteria. In 37% of papers patient numbers were inadequately reported; 20% of papers introduced new statistical methods in the ‘results’ section not previously reported in the ‘methods’ section, and 23% of papers reported no measurement of error with the main outcome measure. Taken together, these issues indicate a general lack of statistical rigour and are consistent with similar reviews undertaken in a number of other scientific and clinical research disciplines. It is imperative that the orthopaedic research community strives to improve the quality of reporting; a failure to do so could seriously limit the development of future research.
Recent publication of reports showing high revision rates for hip and knee replacements carried out in Independent Sector Treatment Centres (ISTCs) has raised doubts regarding their ability to provide high quality healthcare. The high revision rates also create a financial burden to the NHS. The poor quality of data collected at ISTCs makes their performance difficult to evaluate. Funds may be better spent improving existing NHS facilities rather than establishing parallel ISTCs.
This systematic review of the literature summarises
the clinical experience with ceramic-on-ceramic hip bearings over
the past 40 years and discusses the concerns that exist in relation
to the bearing combination. Loosening, fracture, liner chipping
on insertion, liner canting and dissociation, edge-loading and squeaking
have all been reported, and the relationship between these issues
and implant design and surgical technique is investigated. New design
concepts are introduced and analysed with respect to previous clinical
experience.
In this meta-analysis we included 32 English-language articles published between January 1975 and June 2004 on the diagnostic performance of plain radiography, subtraction arthrography, nuclear arthrography and bone scintigraphy in detecting aseptic loosening of the femoral component, using criteria based on the Cochrane systematic review of screening and diagnostic tests. The mean sensitivity and specificity were, respectively, 82% (95% confidence interval (CI) 76 to 87) and 81% (95% CI 73 to 87) for plain radiography and 85% (95% CI 75 to 91) and 83% (95% CI 75 to 89) for nuclear arthrography. Pooled sensitivity and specificity were, respectively, 86% (95% CI 74 to 93) and 85% (95% CI 77 to 91) for subtraction arthrography and 85% (95% CI 79 to 89) and 72% (95% CI 64 to 79) for bone scintigraphy. Although the diagnostic performance of the imaging techniques was not significantly different, plain radiography and bone scintigraphy are preferred for the assessment of a femoral component because of their efficacy and lower risk of patient morbidity.
Although the importance of sound statistical principles in the design and analysis of data has gained prominence in recent years, biostatistics, the application of statistics to the analysis of biological and medical data, is still a subject which is poorly understood and often mishandled. This review introduces, in the context of orthopaedic research, the terminology and the principles involved in simple data analysis, and outlines areas of medical statistics that have gained prominence in recent years. It also lists and provides an insight into some of the more common errors that occur in published orthopaedic journals and which are frequently encountered at the review stage in papers submitted to the
