Aims. Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery. Methods. Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as ‘adequate’, ‘inadequate’, or ‘no information’; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews. Results. We included 917 unique RCTs. We found that 374 RCTs (40.8%) reported adequate sequence generation, 61 (6.7%) were inadequate, 410 (44.7%) lacked information, and 72 (7.9%) were observational studies incorrectly included as RCTs within the systematic review. Publication year, an author with statistical or epidemiological qualifications, and journal impact factor were each associated with adequate randomization. We found that 45 systematic reviews (45%) included at least one inadequately randomized RCT or an observational study incorrectly treated as a RCT. Conclusion. There is evidence of a lack of random allocation in RCTs included in systematic reviews in orthopaedic surgery. The conduct of RCTs and systematic reviews should be improved to minimize the risk of bias from inadequate randomization in RCTs and mislabelling of non-randomized studies as RCTs. Cite this article: Bone Jt Open 2024;5(12):1072–1080

Aims. The aim of this study was to investigate surgeons’ reported change of treatment preference in response to the results and conclusion from a randomized contolled trial (RCT) and to study patterns of change between subspecialties and nationalities. Methods. Two questionnaires were developed through the Delphi process for this cross-sectional survey of surgical preference. The first questionnaire was sent out before the publication of a RCT and the second questionnaire was sent out after publication. The RCT investigated repair or non-repair of the pronator quadratus (PQ) muscle during volar locked plating of distal radial fractures (DRFs). Overall, 380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied. One hundred surgeons were invited to participate in the second questionnaire. The primary outcome was the proportion of surgeons for whom a treatment change was warranted, who then reported a change of treatment preference following the RCT. Secondary outcomes included the reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year. Results. Of the 100 surgeons invited for the second questionnaire, 74 replied. For the primary outcome, six of 32 surgeons (19%), who usually repaired the PQ muscle and therefore a change of treatment preference was warranted, reported a change of treatment preference based on the RCT publication. Of the secondary outcomes, restoring anatomy was the most common response for repairing the PQ muscle. Conclusion. The majority of the orthopaedic surgeons, where a change of treatment preference was warranted based on the results and conclusion of a RCT, did not report willingness to change their treatment preference. Cite this article: Bone Joint Open 2020;1-9:549–555

Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103

Aims. Orthopaedic infection is a potentially serious complication of elective and emergency trauma and orthopaedic procedures, with a high associated burden of morbidity and cost. Optimization of vitamin D levels has been postulated to be beneficial in the prevention of orthopaedic infection. This study explores the role of vitamin D in orthopaedic infection through a systematic review of available evidence. Methods. A comprehensive search was conducted on databases including Medline and Embase, as well as grey literature such as Google Scholar and The World Health Organization Database. Pooled analysis with weighted means was undertaken. Results. Pooled analysis of four studies including 651 patients found the mean 25(OH)D level to be 50.7 nmol/l with a mean incidence of infection of 70%. There was a paucity of literature exploring prophylactic 25(OH)D supplementation on reducing orthopaedic infection, however, there was evidence of association between low 25(OH)D levels and increased incidence of orthopaedic infection. Conclusion. The results indicate a significant proportion of orthopaedic patients have low 25(OH]D levels, as well as an association between low 25(OH)D levels and orthopaedic infection, but more randomized controlled trials need to be conducted to establish the benefit of prophylactic supplementation and the optimum regimen by dose and time. Cite this article: Bone Jt Open 2021;2(9):721–727

Aims. Patients undergoing limb reconstruction surgery often face a challenging and lengthy process to complete their treatment journey. The majority of existing outcome measures do not adequately capture the patient-reported outcomes relevant to this patient group in a single measure. Following a previous systematic review, the Stanmore Limb Reconstruction Score (SLRS) was designed with the intent to address this need for an effective instrument to measure patient-reported outcomes in limb reconstruction patients. We aim to assess the face validity of this score in a pilot study. Methods. The SLRS was designed following structured interviews with several groups including patients who have undergone limb reconstruction surgery, limb reconstruction surgeons, specialist nurses, and physiotherapists. This has subsequently undergone further adjustment for language and clarity. The score was then trialled on ten patients who had undergone limb reconstruction surgery, with subsequent structured questioning to understand the perceived suitability of the score. Results. Ten patients completed the score and the subsequent structured interview. Considering the tool as a whole, 100% of respondents felt the score to be comprehensible, relevant, and comprehensive regarding the areas that were important to a patient undergoing limb reconstruction surgery. For individual questions, on a five-point Likert scale, importance/relevance was reported as a mean of 4.78 (4.3 to 5.0), with ability to understand rated as 4.92 (4.7 to 5.0) suggesting high levels of relevance and comprehension. Flesch-Kincaid reading grade level was calculated as 5.2 (10 to 11 years old). Conclusion. The current SLRS has been shown to have acceptable scores from a patient sample regarding relevance, comprehensibility, and comprehensiveness. This suggests face validity, however further testing required and is ongoing in a larger cohort of patients to determine the reliability, responsiveness, precision, and criterion validity of the score in this patient group. Cite this article: Bone Jt Open 2021;2(9):705–709

Aims. Bone demonstrates good healing capacity, with a variety of strategies being utilized to enhance this healing. One potential strategy that has been suggested is the use of stem cells to accelerate healing. Methods. The following databases were searched: MEDLINE, CENTRAL, EMBASE, Cochrane Database of Systematic Reviews, WHO-ICTRP, ClinicalTrials.gov, as well as reference checking of included studies. The inclusion criteria for the study were: population (any adults who have sustained a fracture, not including those with pre-existing bone defects); intervention (use of stem cells from any source in the fracture site by any mechanism); and control (fracture healing without the use of stem cells). Studies without a comparator were also included. The outcome was any reported outcomes. The study design was randomized controlled trials, non-randomized or observational studies, and case series. Results. In all, 94 eligible studies were identified. The clinical and methodological aspects of the studies were too heterogeneous for a meta-analysis to be undertaken. A narrative synthesis examined study characteristics, stem cell methods (source, aspiration, concentration, and application) and outcomes. Conclusion. Insufficient high-quality evidence is available to determine the efficacy of stem cells for fracture healing. The studies were heterogeneous in population, methods, and outcomes. Work to address these issues and establish standards for future research should be undertaken. Cite this article: Bone Joint Open 2020;1-10:628–638

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Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set.

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The evidence base within trauma and orthopaedics has traditionally favoured quantitative research methodologies. Qualitative research can provide unique insights which illuminate patient experiences and perceptions of care. Qualitative methods reveal the subjective narratives of patients that are not captured by quantitative data, providing a more comprehensive understanding of patient-centred care. The aim of this study is to quantify the level of qualitative research within the orthopaedic literature.

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Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach.

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The principles of evidence-based medicine (EBM) are the foundation of modern medical practice. Surgeons are familiar with the commonly used statistical techniques to test hypotheses, summarize findings, and provide answers within a specified range of probability. Based on this knowledge, they are able to critically evaluate research before deciding whether or not to adopt the findings into practice. Recently, there has been an increased use of artificial intelligence (AI) to analyze information and derive findings in orthopaedic research. These techniques use a set of statistical tools that are increasingly complex and may be unfamiliar to the orthopaedic surgeon. It is unclear if this shift towards less familiar techniques is widely accepted in the orthopaedic community. This study aimed to provide an exploration of understanding and acceptance of AI use in research among orthopaedic surgeons.

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The aim of this study was to develop and evaluate machine-learning-based computerized adaptive tests (CATs) for the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Oxford Shoulder Score (OSS), and the Oxford Elbow Score (OES) and its subscales.

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Tissue adhesives (TAs) are a commonly used adjunct to traditional surgical wound closures. However, TAs must be allowed to dry before application of a surgical dressing, increasing operating time and reducing intraoperative efficiency. The goal of this study is to identify a practical method for decreasing the curing time for TAs.

The response to the COVID-19 pandemic has raised the profile and level of interest in the use, acceptability, safety, and effectiveness of virtual outpatient consultations and telemedicine. These models of care are not new but a number of challenges have so far hindered widespread take-up and endorsement of these ways of working. With the response to the COVID-19 pandemic, remote and virtual working and consultation have become the default. This paper explores our experience of and learning from virtual and remote consultation and questions how this experience can be retained and developed for the future.

Cite this article: Bone Jt Open 2021;2(5):301–304.

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The ongoing COVID-19 pandemic has disrupted and delayed medical and surgical examinations where attendance is required in person. Our article aims to outline the validity of online assessment, the range of benefits to both candidate and assessor, and the challenges to its implementation. In addition, we propose pragmatic suggestions for its introduction into medical assessment.

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To describe the incidence of adverse clinical outcomes related to COVID-19 infection following corticosteroid injections (CSI) during the COVID-19 pandemic. To describe the incidence of positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) testing, positive SARS-COV2 IgG antibody testing or positive imaging findings following CSI at our institution during the COVID-19 pandemic.

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The use of technology to assess balance and alignment during total knee surgery can provide an overload of numerical data to the surgeon. Meanwhile, this quantification holds the potential to clarify and guide the surgeon through the surgical decision process when selecting the appropriate bone recut or soft tissue adjustment when balancing a total knee. Therefore, this paper evaluates the potential of deploying supervised machine learning (ML) models to select a surgical correction based on patient-specific intra-operative assessments.

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Elective operating was halted during the COVID-19 pandemic to increase the capacity to provide care to an unprecedented volume of critically unwell patients. During the pandemic, the orthopaedic department at the Aneurin Bevan University Health Board restructured the trauma service, relocating semi-urgent ambulatory trauma operating to the isolated clean elective centre (St. Woolos’ Hospital) from the main hospital receiving COVID-19 patients (Royal Gwent Hospital). This study presents our experience of providing semi-urgent trauma care in a COVID-19-free surgical unit as a safe way to treat trauma patients during the pandemic and a potential model for restarting an elective orthopaedic service.

It is unusual, if not unique, for three major research papers concerned with the management of the fractured neck of femur (FNOF) to be published in a short period of time, each describing large prospective randomized clinical trials. These studies were conducted in up to 17 countries worldwide, involving up to 80 surgical centers and include large numbers of patients (up to 2,900) with FNOF. Each article investigated common clinical dilemmas; the first paper comparing total hip arthroplasty versus hemiarthroplasty for FNOF, the second as to whether ‘fast track’ care offers improved clinical outcomes and the third, compares sliding hip with multiple cancellous hip screws. Each paper has been deemed of sufficient quality and importance to warrant publication in The Lancet or the New England Journal of Medicine. Although ‘premier’ journals, they only occationally contain orthopaedic studies and thus may not be routinely read by the busy orthopaedic/surgical clinician of any grade. It is therefore our intention with this present article to accurately summarize and combine the results of all three papers, presenting, in our opinion, the most important clinically relevant facts.

Cite this article: Bone Joint Open 2020;1-6:198–202.

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The adequate provision of personal protective equipment (PPE) for healthcare workers has come under considerable scrutiny during the COVID-19 pandemic. This study aimed to evaluate staff awareness of PPE guidance, perceptions of PPE measures, and concerns regarding PPE use while caring for COVID-19 patients. In addition, responses of doctors, nurses, and other healthcare professionals (OHCPs) were compared.

Virtual encounters have experienced an exponential rise amid the current COVID-19 crisis. This abrupt change, seen in response to unprecedented medical and environmental challenges, has been forced upon the orthopaedic community. However, such changes to adopting virtual care and technology were already in the evolution forecast, albeit in an unpredictable timetable impeded by regulatory and financial barriers. This adoption is not meant to replace, but rather augment established, traditional models of care while ensuring patient/provider safety, especially during the pandemic. While our department, like those of other institutions, has performed virtual care for several years, it represented a small fraction of daily care. The pandemic required an accelerated and comprehensive approach to the new reality. Contemporary literature has already shown equivalent safety and patient satisfaction, as well as superior efficiency and reduced expenses with musculoskeletal virtual care (MSKVC) versus traditional models. Nevertheless, current literature detailing operational models of MSKVC is scarce. The current review describes our pre-pandemic MSKVC model and the shift to a MSKVC pandemic workflow that enumerates the conceptual workflow organization (patient triage, from timely care provision based on symptom acuity/severity to a continuum that includes future follow-up). Furthermore, specific setup requirements (both resource/personnel requirements such as hardware, software, and network connectivity requirements, and patient/provider characteristics respectively), and professional expectations are outlined. MSKVC has already become a pivotal element of musculoskeletal care, due to COVID-19, and these changes are confidently here to stay. Readiness to adapt and evolve will be required of individual musculoskeletal clinical teams as well as organizations, as established paradigms evolve.

Cite this article: Bone Joint Open 2020;1-6:272–280.