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

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

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.

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

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The aim of this study was to identify the information topics that should be addressed according to the parents of children with developmental dysplasia of the hip (DDH) in the diagnostic and treatment phase during the first year of life. Second, we explored parental recommendations to further optimize the information provision in DDH care.

Introduction. In 2015, the healthcare system transitioned from International Classification of Diseases, Ninth Revision (ICD-9) coding to the Tenth Revision (ICD-10). Given that administrative claims are used for quality initiatives, risk adjustment models and clinical research, we sought to determine the effect of new, more detailed coding on the incidence of complications following primary total knee arthroplasty (TKA). Methods. The Humana administrative claims database was queried from 2-years prior to October 1, 2015 (ICD-9 cohort) and for 1-year after this date (ICD-10 cohort) to identify all primary TKA procedures. Each TKA was then tracked for occurrence of an arthroplasty specific post-operative complication within 6 months of surgery using the respective coding systems. Laterality and joint specific codes were utilized for the ICD-10 cohort to ensure complications occurred on the same side and joint as the index procedure. Incidence of each complication was compared between cohorts using risk ratios (RR) and 95% confidence intervals. Results. There were 19,009 TKAs in the ICD-10 cohort and 38,172 TKAs in the ICD-9 cohort. The incidence of each post-operative complication analyzed was significantly higher in the ICD-9 cohort relative to the ICD-10 cohort (Figure 1). Comparing ICD-9 cohort to ICD-10 cohort, PJI occurred in 1.9% vs 1.3% (RR 1.5), loosening in 0.3% vs 0.1% (RR 2.7), periprosthetic fracture in 0.3% vs 0.1% (RR 3.0) and other mechanical complications in 0.7% vs 0.4% (RR 2.0), respectively (p < 0.05 for all). These findings remained significant when subgroup analyses were performed to control for seasonal variation between groups. Conclusion. The transition from ICD-9 to ICD-10 coding has dramatically altered the reported incidence of complications following TKA. These results are likely due to the added complexity of ICD-10 which is joint and laterality specific. It is important to quantify and understand the differences between coding systems as this data is used for quality initiatives, risk adjustment models and clinical research. Thoughtful methodology will be necessary for future research if both ICD-9 and ICD-10 data are being analyzed simultaneously. Furthermore, additional studies are needed to compare the hospital billing data for complex diagnoses or revision procedures to coding performed by skilled researchers in the field. For figures, tables, or references, please contact authors directly

Aims

The aims of this study were to identify and evaluate the current literature examining the prognostic factors which are associated with failure of total elbow arthroplasty (TEA).

Bone non-union following fracture is a major cause of morbidity in combat casualties. The various clinical treatments used to prevent or treat non-union remain of limited efficacy. Research therefore continues in pre-clinical animal models in an attempt to identify an effective clinical treatment. The aim of this study was to systematically evaluate emerging pre-clinical therapies in order to rationalise priorities for translational research. The methodological protocol of this study was registered with the Collaborative Approach to Meta Analysis and Review of Animal Data from Experimental Studies (CAMARADES) and published. The review identified 3251 animal studies, 851 of which fulfilled the criteria for inclusion as detailed in the protocol. Of these, 702 of the studies described therapies that had progressed to clinical trials and were therefore excluded. The remaining 149 papers described eighteen categories of therapy that represent novel therapies yet to translate to clinical trials. These studies used a range of animal models, with heterogeneity that precluded formal synthesis and meta-analysis. This study provides a systematic evaluation of novel therapies with potential to prevent or treat non-union. It also represents a novel application of an emerging epidemiological technique to address a key priority in Combat Casualty Care research

Introduction: Following a systematic review of the literature, de Kleuver. 1. concluded that there was insufficient data to assess the performance of total disc replacement. In the absence of controlled trials, the relative merits and efficacy of artificial disc replacement as a treatment option for degenerative disc disease was unproven. Observational studies reported a moderate success rate (50-81%), but a relatively high complication rate (3%–50%). In particular, 4% of the operated levels fused spontaneously or after revision surgery. Methods: Using the research methodology of the above study, all subsequent published studies of artificial lumbar disc replacement were identified and reviewed by meta-analysis. In the two years (2002–2003) since the above study, a further nine case series and three controlled studies have been reported. The three randomised controlled trials compared disc replacement with spinal fusion. Seven prospective studies (include the randomised controlled studies) had defined indications, exclusions and outcome measures. Results: A total of 623 disc replacements were performed in 510 patients. The outcomes were classified as “good” or “excellent”, ranged from 70–93% (mean=83%). Complications were observed in up to 35% (mean=3%) of patients. Eight patients subsequently underwent spinal arthrodesis at the level of the disc replacement. Two patients were reported to have heterotopicossification. The outcomes for the 2002–2003 publications were better (MWp=0.02) than for the de Kleuver study. Fewer patients had disc replacement at more than one level (FEp< 0.01). The number of patients undergoing secondary surgery (FEp< 0.01) and arthrodesis (FEp=0.04) was less and the incidence of prosthetic subsidence or migration was lower (FEp=0.28). This overall improvement in recent studies highlights the importance of patient selection and the use of a disc replacement of appropriate size. Following disc replacement, there was a significant improvement in outcome measures at six-week follow-up. This improvement was maintained at two years. While disc replacement reported significantly less pain and disability in the early period following surgery compared with the fusion, the difference was not significant by six months. Discussion: In the short to medium term, disc replacement is as effective as spinal fusion in the treatment of degenerative disc disease in critically selected patients. Although the number of complications has been reduced, some serious complications were reported. 2. A satisfactory salvage procedure for failed disc replacement is yet to be found. The long-term biological effects of disc replacement are unknown. Late failure of disc replacement is predictable in a substantial number of patients. Long-term studies of ten or more years are necessary to adequately define the place of disc replacement in the treatment of lumbar disc disorders. Because the numbers of disc replacement patients is likely to be small, protocols and outcome measures should be standardised and data centrally recorded

Cite this article: Bone Joint Res 2022;11(8):514–517.

The optimal method of fixation for primary total hip replacements (THR), particularly fixation with or without the use of cement is still controversial. In a systematic review and meta-analysis of all randomized controlled trials (RCT) comparing cemented versus uncemented THRS available in the published literature, we found that there is no significant difference between cemented and uncemented THRs in terms implant survival as measured by the revision rate. Better short-term clinical outcome, particularly an improved pain score can be obtained with cemented fixation. However, the results are unclear for the long-term clinical and functional outcome between the two groups. No difference was evident in the mortality and the post operative complication rate. On the other hand, the Radiographic findings were variable and do not seem to correlate with clinical findings as differences in the surgical technique and prosthesis design might be associated with the incidence of osteolysis. We concluded in our review that Cemented THR is similar if not superior to uncemented THR, and provides better short term clinical outcomes. Further research, improved methodology and longer follow up are necessary to better define specific subgroups of patients in whom the relative benefits of cemented and uncemented implant fixation can be clearly demonstrated