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.

Aims. 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. Methods. A bibliometric search of journals’ online archives and multiple databases was undertaken in March 2024, to identify articles using qualitative research methods in the top 12 trauma and orthopaedic journals based on the 2023 impact factor and SCImago rating. The bibliometric search was conducted and reported in accordance with the preliminary guideline for reporting bibliometric reviews of the biomedical literature (BIBLIO). Results. Of the 7,201 papers reviewed, 136 included qualitative methods (0.1%). There was no significant difference between the journals, apart from Bone & Joint Open, which included 21 studies using qualitative methods, equalling 4% of its published articles. Conclusion. This study demonstrates that there is a very low number of qualitative research papers published within trauma and orthopaedic journals. Given the increasing focus on patient outcomes and improving the patient experience, it may be argued that there is a requirement to support both quantitative and qualitative approaches to orthopaedic research. Combining qualitative and quantitative methods may effectively address the complex and personal aspects of patients’ care, ensuring that outcomes align with patient values and enhance overall care quality

Controversy persists over whether cemented or uncemented fixation is more effective in reducing revision and mortality risks following primary total hip arthroplasty (THA). Despite a shift towards uncemented THA in Europe, Australia, and the US, no consensus exists on superior outcomes. This ambiguity in evidence from randomized controlled trials (RCTs) and observational studies necessitates advanced research methodologies to derive more definitive conclusions. This study investigates the causal impact of THA fixation type on 2-year and 5-year revision rates, along with 90-day mortality, utilizing a regression discontinuity (RD) design in scenarios where fixation choice is guided by patient age. Employing data from the Dutch Arthroplasty Register, we conducted a cohort study on primary THAs for osteoarthritis from 2007 to 2019. A “fuzzy” RD design was executed to compute the Local Average Treatment Effect for subjects around the age-based selection threshold for fixation type. The main outcome of interest was the revision rate at 2 years post-operation. Analysis for the 2-year revision endpoint, covering any cause, included 2,344 females and 1,671 males across 5 hospitals each, with no significant variation in revision rates observed. For the 5-year mark, 1,058 females in 3 hospitals and 214 males in 1 hospital were examined, similarly showing no significant differences. Mortality within 90 days post-operation was also investigated in 5 female and 7 male cohorts, with 2,180 and 2,145 surgeries respectively, yielding no substantial disparities. In conclusion, the RD analysis revealed no notable differences in revision rates at 2 and 5 years or in early mortality based on the fixation method used in THA. These outcomes suggest that the age-based preference for THA fixation may not influence the revision or mortality risk, underscoring the value of RD design in deriving causal insights from observational data

Aims. The diagnosis of periprosthetic joint infection (PJI) continues to present a significant clinical challenge. New biomarkers have been proposed to support clinical decision-making; among them, synovial fluid alpha-defensin has gained interest. Current research methodology suggests reference methods are needed to establish solid evidence for use of the test. This prospective study aims to evaluate the diagnostic accuracy of high-performance liquid chromatography coupled with the mass spectrometry (LC-MS) method to detect alpha-defensin in synovial fluid. Methods. Between October 2017 and September 2019, we collected synovial fluid samples from patients scheduled to undergo revision surgery for painful total knee arthroplasty (TKA). The International Consensus Meeting criteria were used to classify 33 PJIs and 92 aseptic joints. LC-MS assay was performed to measure alpha-defensin in synovial fluid of all included patients. Sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve (AUC) were calculated to define the test diagnostic accuracy. Results. The AUC was 0.99 (95% confidence interval (CI) 0.98 to 1.00). Receiver operating characteristic (ROC) analysis showed that the optimal cut-off value of synovial fluid alpha-defensin was 1.0 μg/l. The sensitivity of alpha-defensin was 100% (95% CI 96 to 100), the specificity was 97% (95% CI 90 to 98), the positive predictive value was 89.2% (95% CI 82 to 94), and negative predictive value was 100% (95% CI 96 to 100). ROC analysis demonstrated an AUC of 0.99 (95% CI 0.98 to 1.0). Conclusion. The present study confirms the utility of alpha-defensin in the synovial fluid in patients with painful TKA to select cases of PJI. Since LC-MS is still a time-consuming technology and is available in highly specialized laboratories, further translational research studies are needed to take this evidence into routine procedures and promote a new diagnostic approach. Cite this article: Bone Joint J 2022;104-B(9):1047–1051

Abstract. Purpose. Clinical registries are an important aspect of orthopaedic research in assessing the outcomes of surgical intervention and track medical devices. This study aimed to explore the research methodology available to account for patients lost to follow-up (LTFU) specifically in studies related to arthroscopic intervention and whether the rates of patient LTFU are within the acceptable margins for survey studies. Methods. A scoping review, where a literature search for studies from nine arthroscopy registries, was performed on EMBASE, MEDLINE, and the annual reports of each registry. Inclusion criteria included studies with information on patient-reported outcome measures and being based on nine national registries identified. Exclusion criteria included review articles, conference abstracts, studies not based on registry data, and studies from regional, claims-based, or multi-centre registries. Studies were then divided into categories based on method of LTFU analysis used. Results. Thirty-six articles were identified for the final analysis. Categories for LTFU analysis included dropout analyses (n=10), referencing validation studies (n=12), contacting non-responders (n=4), and sensitivity analyses (n=1). Referencing validation studies was the most common method (n=12). Majority (n=35) of the studies exceeded the recommended maximum rates for LTFU. Conclusions. Most arthroscopy studies have rates of LTFU higher than traditionally acceptable. Therefore, any conclusions drawn from these research papers may not be sufficiently valid or free from non-response bias

Aim. To systematically review the literature and anatomical atlases on LM morphology. Methods. Relevant studies were searched in PubMed (Medline) and Science Direct. Anatomical atlases were retrieved from multiple university libraries and online. Included atlases and studies were assessed at five items: visuals present(y/n), quality of visuals(in-/sufficient), labelling of multifidus (y/n), clear description of region of interest(y/n), description of plane has been described(y/n). This risk of bias assessment tool was developed to assess the quality of description of anatomy, since existing risk of bias tables have only been developed to assess the methodology of studies. Results. In total 69 studies and 19 anatomical atlases were included. Studies. - 52 of 69 studies, LM was described as a superficial muscle at the levels L4 – S1. Others presented the LM as deep intrinsic muscle. - Most used methods: MRI, ultrasound imaging or drawings. - 32 of 69 studies scored a total of five points at the risk of bias assessment, which means low risk of bias. Anatomical atlases. - LM is shown as a deep intrinsic back muscle covered by the erector spinae and fascia thoracolumbalis. - Most anatomical atlases (8/19) had a score of four points at the risk of bias assessment. Conclusion. Anatomy atlases reported different LM morphology compared to anatomical studies. Even between studies, there appears to be inconsistent reporting in LM anatomy. Variation in research methods that are used for measuring LM morphology could influence variation in describing and presenting LM morphology. Standardization of research methodology is recommended in order to compare studies. No conflicts of interest. Sources of Funding: SIA RAAK-Publiek

A commonly misunderstood principle in medical literature is statistical significance. Often, statistically non-significant or negative results are thought to be evidence for equivalence; mistakenly validating treatment modalities and putting patients at risk. This study examines the prevalence of misinterpretation of negative results of superiority trials in orthopaedic literature and outlines the need for a non-inferiority or equivalence research design. Four orthopaedic journals – Journal of Paediatric Orthopaedics A, Journal of Bone and Joint Surgery American Volume, Journal of Arthroplasty and Journal of Shoulder and Elbow Surgery – were hand searched to identify all randomised control trials (RCTs) published within the time periods 2002–2003, 2007–2008 and 2012–2013. The identified RCTs were read and classified by study methodology, results obtained, and interpretation of results. A total of 237 RCTs were identified. When analysing the primary outcomes, 117 (49.4%) studies yielded negative results and 120 (50.8%) yielded positive results. Out of the 237 articles, 231 (97.5%) used superiority methodology and 6 (2.5%) used non-inferiority or equivalence methodology. Of the 231 studies that used superiority methodology, 115 (49.8%) obtained negative results; and 45 (39.1%) of those misinterpreted the negative results for equivalence. While no statistical differences were seen, there was an upward trend in utilising non-inferiority and equivalence methodologies over time. Given the frequency of misinterpreted negative results, there is an evident need for a more appropriate research methodology that shows equivalence of treatment methods. A non-inferiority or equivalence study design can address orthopaedic clinical dilemmas more suitably when trying to show one treatment is no worse or is equal to another treatment. Regarding orthopaedic treatment modalities as equivalent when studies show negative statistical results can be detrimental to patients and their clinical outcomes. A non-inferiority methodology can be used to accurately depict no difference between treatment methods rather than attempting to show one treatment method as superior

The World Health Organisation (WHO) has recently identified musculoskeletal care as a major global health issue in the developing world. However, little is known about the quality and trends of orthopaedic research in resource-poor settings. The purpose of this study was to perform a systematic review of orthopaedic research in low-income countries (LIC). The primary objective was to determine the quality and publication parameters of studies performed in LIC. Secondary objectives sought to provide recommendations for successful strategies to implement research endeavors in LIC. A systematic review of the literature was performed by searching MEDLINE (1966-November 2014), EMBASE and the Cochrane Library to identify peer-reviewed orthopaedic research conducted in LICs. The PRISMA guidelines for performing a systematic review were followed. LIC were defined by the WHO and by the World Bank as countries with gross national income per capita equal or less than 1045US$. Inclusion criteria were (1) studies performed in a LIC, (2) conducted on patients afflicted by an orthopaedic condition, and (3) evaluated either an orthopaedic intervention or outcome. The Oxford Centre for Evidence-Based Medicine Levels of Evidence, and Grading of Recommendations Assessment, Development and Evaluation (GRADE) were used to objectively rate the overall methodological quality of each study. Additional data collected from these studies included the publication year, journal demographics, orthopaedic subspecialty and authors' country of origin. A total of 1,809 articles were screened and 277 studies met our inclusion criteria. Eighty-eight percent of studies conducted in LIC were of lower quality evidence according to the GRADE score and consisted mostly of small case series or case reports. Bangladesh and Nepal were the only two LIC with national journals and produced the highest level of research evidence. Foreign researchers produced over 70% of the studies with no collaboration with local LIC researchers. The most common subspecialties were trauma (42%) and paediatrics (14%). The 3 most frequent countries where the research originated were the United States (42%), United Kingdom (11%), and Canada (8%). The 3 most common locations where research was conducted were Haiti (18%), Afghanistan (14%), and Malawi (7%). The majority of orthopaedic studies conducted in LIC were of lower quality and performed by foreign researchers with little local collaboration. In order to promote the development of global orthopaedic surgery and research in LIC, we recommend (1) improving the collaboration between researchers in developed and LIC, (2) promoting the teaching of higher-quality and more rigorous research methodology through shared partnerships, (3) improving the capacity of orthopaedic research in developing nations through national peer-reviewed journals, and (4) dedicated subsections in international orthopaedic journals to global healthcare research

A systematic search of the literature published between January 1985 and February 2006 identified 62 studies which reported the results of arthroscopic procedures for chronic anterior shoulder instability or comparisons between arthroscopic and open surgery. These studies were classified by surgical technique and research methodology, and when appropriate, were included in a meta-analysis. The failure rate of arthroscopic shoulder stabilisation using staples or transglenoid suture techniques appeared to be significantly higher than that of either open surgery or arthroscopic stabilisation using suture anchors or bio-absorbable tacks. Arthroscopic anterior stabilisation using the most effective techniques has a similar rate of failure to open stabilisation after two years

The October 2023 Research Roundup³⁶⁰ looks at: Gut microbiota in high-risk individuals for rheumatoid arthritis associated with disturbed metabolome and initiates arthritis by triggering mucosal immunity imbalance; International Consensus on Anaemia Management in Surgical Patients (ICCAMS); Sleep disturbance trends in the short-term postoperative period for patients undergoing total joint replacement; Achilles tendon tissue turnover before and immediately after an acute rupture; Quadriceps or hip exercises for patellofemoral pain? A randomized controlled equivalence trial; Total-body MRI for screening in patients with multiple osteochondromas.

The subject of noise in the operating theatre was recognized as early as 1972 and has been compared to noise levels on a busy highway. While noise-induced hearing loss in orthopaedic surgery specifically has been recognized as early as the 1990s, it remains poorly studied. As a result, there has been renewed focus in this occupational hazard. Noise level is typically measured in decibels (dB), whereas noise adjusted for human perception uses A-weighted sound levels and is expressed in dBA. Mean operating theatre noise levels range between 51 and 75 dBA, with peak levels between 80 and 119 dBA. The greatest sources of noise emanate from powered surgical instruments, which can exceed levels as high as 140 dBA. Newer technology, such as robotic-assisted systems, contribute a potential new source of noise. This article is a narrative review of the deleterious effects of prolonged noise exposure, including noise-induced hearing loss in the operating theatre team and the patient, intraoperative miscommunication, and increased cognitive load and stress, all of which impact the surgical team’s overall performance. Interventions to mitigate the effects of noise exposure include the use of quieter surgical equipment, the implementation of sound-absorbing personal protective equipment, or changes in communication protocols. Future research endeavours should use advanced research methods and embrace technological innovations to proactively mitigate the effects of operating theatre noise.

Cite this article: Bone Joint J 2024;106-B(10):1039–1043.

Aims

Shoulder arthroplasty is effective in the management of end-stage glenohumeral joint arthritis. However, it is major surgery and patients must balance multiple factors when considering the procedure. An understanding of patients’ decision-making processes may facilitate greater support of those considering shoulder arthroplasty and inform the outcomes of future research.

Aims

With up to 40% of patients having patellofemoral joint osteoarthritis (PFJ OA), the two arthroplasty options are to replace solely the patellofemoral joint via patellofemoral arthroplasty (PFA), or the entire knee via total knee arthroplasty (TKA). The aim of this study was to assess postoperative success of second-generation PFAs compared to TKAs for patients treated for PFJ OA using patient-reported outcome measures (PROMs) and domains deemed important by patients following a patient and public involvement meeting.

Introduction: Elective joint replacement patients routinely require transfusion following surgery. Haemoglobin must remain within red blood cells in order to be functional. The process of surgery and collection in the reinfusion drain may disrupt cell membranes resulting in non functional haemoglobin. The filtration and collection process does not eliminate free haemoglobin. This results in intracellular and free haemoglobin being transfused into patients giving false functional haemoglobin levels. Aim: To determine the proportion of intracellular haemoglobin in autologous blood transfusion drain following joint replacement. Research Methodology: Research ethical approval was obtained prior to conducting this study. 20 consecutive patients undergoing elective total hip replacement (THR) and 20 consecutive patients undergoing elective knee replacement (TKR) from April 08–July 08 were consented to participate in this study. A standard full blood count sample of 3 mls was taken from the rein-fused blood. Each sample had the total haemoglobin (THb) concentration determined (i.e. free and intra-cellular) from the blood in the specimen tube. The sample was then centrifuged, and the THb of the supernatant was determined. This determined the concentation of ‘free’ haemoglobin. From these two respective values, the proportion of haemolysed haemoglobin was determined from each sample. Results: There were a total of 35 participants of which 20 were TKR and 15 were THR. The average THb concentration for the THR and TKR were 7.7g/dl and 10.3g/dl respectively. The proportion of haemolysed Hb was 1.46% and 0% respectively. The THb and proportion of haemolysed Hb for all 35 patients were 8.76g/dl and 0.63%. Conclusion: Autologous blood transfusion is not only safe and economical but remains an effective procedure with a negligible proportion of haemolysis

Aims

Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments.

Aims

In this study, we aimed to visualize the spatial distribution characteristics of femoral head necrosis using a novel measurement method.