Data of high quality are critical for the meaningful interpretation of registry information. The National Joint Registry (NJR) was established in 2002 as the result of an unexpectedly high failure rate of a cemented total hip arthroplasty. The NJR began data collection in 2003. In this study we report on the outcomes following the establishment of a formal data quality (DQ) audit process within the NJR, within which each patient episode entry is validated against the hospital unit’s Patient Administration System and vice-versa. This process enables bidirectional validation of every NJR entry and retrospective correction of any errors in the dataset. In 2014/15 baseline average compliance was 92.6% and this increased year-on-year with repeated audit cycles to 96.0% in 2018/19, with 76.4% of units achieving > 95% compliance. Following the closure of the audit cycle, an overall compliance rate of 97.9% was achieved for the 2018/19 period. An automated system was initiated in 2018 to reduce administrative burden and to integrate the DQ process into standard workflows. Our processes and quality improvement results demonstrate that DQ may be implemented successfully at national level, while minimizing the burden on hospitals. Cite this article: Bone Jt Open 2022;3(9):716–725

The patient-reported Manchester-Oxford Foot Questionnaire (MOXFQ), with 3 dimensions (Walking/standing(W/S), Pain, Social interaction(SI)) has previously been validated in patients undergoing hallux valgus surgery. A preliminary cross-sectional evaluation of its measurement properties relating to surgery on different regions of the foot and ankle is presented here.

Within 4 weeks prior to foot or ankle surgery, 671of 764 consecutive eligible patients (87.8% response rate) were assessed with the: (i) MOXFQ questionnaire, (ii) SF-36 general health survey (iii) American Orthopaedic Foot & Ankle Society (AOFAS) scales. Sample characteristics: mean age 53 years 427 (63.6%) female. Patients were booked for (main) surgery on Hallux (210, 31.3%), Lesser Toes (119, 17.7%), Mid foot (22, 3.3%), Ankle/Hind foot (311, 46.3%) and whole foot/multiple regions (9, 1.3%)

MOXFQ item response rates were high (<2% missing on any one item) with responses generally well distributed across response categories. Item-total correlations within each dimension were generally above recommended levels. Internal consistency, as assessed by Cronbach's alpha, were 0.93, 0.84 and 0.71 for the W/S, Pain and SI dimensions, respectively. Within Hallux, Lesser toes and Ankle/hind foot surgical subgroups (low numbers precluded mid foot and whole/multiple region analyses), alphas for these subscales were similar. Convergent validity of MOXFQ was demonstrated by correlations between the 3 dimensions (W/S, Pain, SI) with similar dimensions of the SF-36 and relevant AOFAS scales. A priori hypotheses were generally supported.

The MOXFQ demonstrates good baseline measurement properties in patients undergoing a range of foot and ankle surgery, suggesting its suitability as an outcome measure for clinical trials of foot and ankle surgery in general. The SI dimension, concerned with cosmesis and social participation has somewhat weaker properties but remains useful. Evidence for the MOXFQ's responsiveness across the range of foot and ankle surgery is yet to be assessed.

There is limited evidence for the effects of ordering and length on responses to questionnaires used in the health field. Multiple outcome measures used in back pain studies have implications for respondent burden and response quality. This randomised study assessed the effect of questionnaire ordering and length on missing data and internal reliability for two health outcome measures.

Back pain patients were recruited from 26 UK practices in the UK BEAM feasibility study. Patients were randomised to receive a 27 page self-completed questionnaire with the Roland Disability Questionnaire (RDQ) at the front and SF-36 at the back of the questionnaire, or vice versa.

The mean number of missing items for the SF-36 was 0.07 (sd=0.68) and 0.56 (sd=2.73) at the front and back of the questionnaire; this difference was statistically significant (p< 0.05) for the general health perception scale. The internal consistency (Cronbach’s Alpha) of the RDQ was unaffected by questionnaire positioning; but was generally higher when the SF-36 (mean difference = 0.03) was at the start of the questionnaire and statistically significant for the vitality scale (p< 0.01).

The positioning of instruments affects patients’ responses. Researchers should consider the influence of questionnaire design. Primary measures should be positioned at the front of questionnaires.

Introduction. External fixators are common surgical orthopaedic treatments for the management of complex fractures and in particular, the use of circular frame fixation within patients requiring limb reconstruction. It is well known that common complications relating to muscle length and patient function without rehabilitation can occur. Despite this there remains a lack of high-quality clinical trials in this area investigating the role of physiotherapy or rehabilitation in the management of these patients. We aim to complete a systematic review of rehabilitation techniques for patients undergoing external fixator treatment for Limb Reconstruction of the lower limb. Materials & Methods. A comprehensive search of AMED, CINAHL, MEDLINE and COCHRANE databases was conducted to identify relevant articles for inclusion, using a search strategy developed in collaboration with a research librarian. Inclusion criteria consisted of adults aged 18 years and over who have experienced leg trauma (open fracture, soft tissue damage), elective leg deformity corrective surgery, bone infection or fracture non-union who have been treated with the use of an external fixator for fixation. Specific exclusion criteria were patients below the age of 18 years old, patients with cancer, treatment of the injury with internal nail, patients who underwent amputation, the use of external fixators for soft tissue contracture management, editorials, comment papers, review papers, conference proceedings and non-English papers. Titles, abstracts, and full texts were screened for suitability by pairs of reviewers according to the inclusion and exclusion criteria using Rayyan QCRI online software. Any conflicts were resolved through discussion with three independent specialist senior reviewers. Following full text screening, references lists of included articles were manually searched to ensure that all relevant studies were identified. Due to lack of evidence, forward searching was also completed for studies included in the review. Data quality was assessed using the mixed methods appraisal tool and the CERT assessment tool was utilised to look at completeness of reporting of exercise interventions. Results. A total number of 832 articles were initially retrieved from our search once duplicate articles removed. After title and abstract screening, 45 articles remained for full text screening. Of these, 11 articles met our inclusion criteria and included for data extraction. Conclusions. We expect high variability of results due to our inclusion criteria and therefore plan to conduct a narrative synthesis to summarise the findings whilst measing against the mixed methods appraisal tool and CERT assessment scores to assess the data quality. We anticipate lower assessment scores within the fewer articles found and therefore poorer-quality data. We currently are in the process of finalising this data extraction. This will be completed ready for submission and potential presentation at the BLRS conference in March 2023

Aims. The French registry for complex bone and joint infections (C-BJIs) was created in 2012 in order to facilitate a homogeneous management of patients presented for multidisciplinary advice in referral centres for C-BJI, to monitor their activity and to produce epidemiological data. We aimed here to present the genesis and characteristics of this national registry and provide the analysis of its data quality. Methods. A centralized online secured database gathering the electronic case report forms (eCRFs) was filled for every patient presented in multidisciplinary meetings (MM) among the 24 French referral centres. Metrics of this registry were described between 2012 and 2016. Data quality was assessed by comparing essential items from the registry with a controlled dataset extracted from medical charts of a random sample of patients from each centre. Internal completeness and consistency were calculated. Results. Between 2012 and 2016, 30,607 presentations in MM were recorded corresponding to 17,748 individual patients (mean age 62.1 years (SD 18.4); 10,961 (61.8%) males). BJI was considered as complex for 63% of cases (n = 19,355), and 13,376 (44%) had prosthetic joint infections (PJIs). The controlled dataset, available for 19 centres, included 283 patients. Global consistency and completeness were estimated at 88.2% and 88.9%, respectively, considering missing items in the eCRFs as negative results. Conclusion. This national registry is one of the largest prospective databases on BJI and its acceptable data quality parameters allow further use for epidemiological purposes. Cite this article: Bone Joint Res 2020;9(9):635–644

Aims. An objective technological solution for tracking adherence to at-home shoulder physiotherapy is important for improving patient engagement and rehabilitation outcomes, but remains a significant challenge. The aim of this research was to evaluate performance of machine-learning (ML) methodologies for detecting and classifying inertial data collected during in-clinic and at-home shoulder physiotherapy exercise. Methods. A smartwatch was used to collect inertial data from 42 patients performing shoulder physiotherapy exercises for rotator cuff injuries in both in-clinic and at-home settings. A two-stage ML approach was used to detect out-of-distribution (OOD) data (to remove non-exercise data) and subsequently for classification of exercises. We evaluated the performance impact of grouping exercises by motion type, inclusion of non-exercise data for algorithm training, and a patient-specific approach to exercise classification. Algorithm performance was evaluated using both in-clinic and at-home data. Results. The patient-specific approach with engineered features achieved the highest in-clinic performance for differentiating physiotherapy exercise from non-exercise activity (area under the receiver operating characteristic (AUROC) = 0.924). Including non-exercise data in algorithm training further improved classifier performance (random forest, AUROC = 0.985). The highest accuracy achieved for classifying individual in-clinic exercises was 0.903, using a patient-specific method with deep neural network model extracted features. Grouping exercises by motion type improved exercise classification. For at-home data, OOD detection yielded similar performance with the non-exercise data in the algorithm training (fully convolutional network AUROC = 0.919). Conclusion. Including non-exercise data in algorithm training improves detection of exercises. A patient-specific approach leveraging data from earlier patient-supervised sessions should be considered but is highly dependent on per-patient data quality. Cite this article: Bone Joint Res 2023;12(3):165–177

Adult Spine Deformity (ASD) is a degenerative condition of the adult spine leading to altered spine curvatures and mechanical balance. Computational approaches, like Finite Element (FE) Models have been proposed to explore the etiology or the treatment of ASD, through biomechanical simulations. However, while the personalization of the models is a cornerstone, personalized FE models are cumbersome to generate. To cover this need, we share a virtual cohort of 16807 thoracolumbar spine FE models with different spine morphologies, presented in an online user-interface platform (SpineView). To generate these models, EOS images are used, and 3D surface spine models are reconstructed. Then, a Statistical Shape Model (SSM), is built, to further adapt a FE structured mesh template for both the bone and the soft tissues of the spine, through mesh morphing. Eventually, the SSM deformation fields allow the personalization of the mean structured FE model, leading to generate FE meshes of thoracolumbar spines with different morphologies. Models can be selectively viewed and downloaded through SpineView, according to personalized user requests of specific morphologies characterized by the geometrical parameters: Pelvic Incidence; Pelvic Tilt; Sacral Slope; Lumbar Lordosis; Global Tilt; Cobb Angle; and GAP score. Data quality is assessed using visual aids, correlation analyses, heatmaps, network graphs, Anova and t-tests, and kernel density plots to compare spinopelvic parameter distributions and identify similarities and differences. Mesh quality and ranges of motion have been assessed to evaluate the quality of the FE models. This functional repository is unique to generate virtual patient cohorts in ASD. Acknowledgements: European Commission (MSCA-TN-ETN-2020-Disc4All-955735, ERC-2021-CoG-O-Health-101044828)

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

Gait measurements can vary due to various intrinsic and extrinsic factors, and this variability becomes more pronounced using inertial sensors in a free-living environment. Therefore, identifying and quantifying the sources of variability is essential to ensure measurement reliability and maintain data quality. This study aimed to determine the variability of daily accelerations recorded by an inertial sensor in a group of healthy individuals. Ten participants, four males and six females, with a mean age of 50 years (range: 29–61) and BMI of 26.9 kg/m. 2. (range: 21.4–36.8), were included. A single accelerometer continuously recorded lower limb accelerations over two weeks. We extracted and analyzed the accelerations of three consecutive strides within walking bouts if the time difference between the bouts was more than two hours. Multivariate mixed-effects modeling was performed on both the discretized acceleration waveforms at 101 points (0–100) and the harmonics of the signals in the frequency domain to determine the variance components for different subjects, days, bouts, and steps as the random effect variables. Intraclass correlation coefficients (ICCs) were calculated for between-day, between-bout, and between-step comparisons. The results showed that the ICCs for the between-day, between-bout, and between-step comparisons were 0.73, 0.82, 0.99 for the vertical axis; 0.64, 0.75, 0.99 for the anteroposterior axis; and 0.55, 0.96, 0.97 for the mediolateral axis. For the signal harmonics, the respective ICCs were 0.98, 0.98, 0.99 for the vertical axis; 0.54, 0.93, 0.98 for the anteroposterior axis; and 0.69, 0.78, 0.95 for the mediolateral axis. Overall, this study demonstrated that accelerations recorded continuously for multiple days in a free-living environment exhibit high variability, mainly between days, and some variability arising from differences between walking bouts during different times within days. However, reliable and repeatable gait measurements can be obtained by identifying and quantifying the sources of variability

Artificial intelligence and machine-learning analytics have gained extensive popularity in recent years due to their clinically relevant applications. A wide range of proof-of-concept studies have demonstrated the ability of these analyses to personalize risk prediction, detect implant specifics from imaging, and monitor and assess patient movement and recovery. Though these applications are exciting and could potentially influence practice, it is imperative to understand when these analyses are indicated and where the data are derived from, prior to investing resources and confidence into the results and conclusions. In this article, we review the current benefits and potential limitations of machine-learning for the orthopaedic surgeon with a specific emphasis on data quality

Given the low prevalence of sarcoma, international cooperation is necessary to recruit sufficient numbers of patients for surgical trials. The PARITY (Prophylactic Antibiotic Regimens in Tumour Surgery) trial is the first international multicentre trial in orthopedic oncology and successfully achieved target enrollment of 600 patients across 12 countries. It is important to reflect upon the challenges encountered and experiences gained to inform future trials. The objective of this study is to describe recruitment patterns and examine the differences in enrollment across different PARITY sites and identify variables associated with varying levels of recruitment. Data from this study was obtained from the PARITY trial Methods Centre and correspondence data. We performed descriptive statistics to demonstrate the recruitment patterns over time. We compared recruitment, time to set up, and time to enroll the first patient between North American and international sites, and sites that had dedicated research personnel. Two-tailed non-paired t-tests were performed to compare average monthly recruitment rates between groups with significance being set at alpha=0.05. A total of 600 patients from 48 clinical sites and 12 countries were recruited from January 2013 through to October 2019. Average monthly enrollment increased every year of the study. There were 36 North American and 12 international sites. North American sites were able to set up significantly faster than international sites (19.3 vs. 28.3 months p=0.037). However, international sites had a significantly higher recruitment rate per month once active (0.2/month vs. 0.62/month, p=0.018). Of active sites, 40 (83%) had research support personnel and 8 (17%) sites did not. Sites with research personnel were able to reach ‘enrolment ready’ status significantly faster than sites without research support (19.6 vs. 30.7 months, p=0.032). However, there was no significant difference in recruitment rate per month once the sites began enrolling (0.28/month vs. 0.2/month, p=0.63). Trial sites that took longer than 1 year to recruit their first patient had 3x lower average recruitment rate compared to sites that were able to recruit their first patient within a year of being enrolment ready. The PARITY trial is the first multicentre RCT in orthopaedic oncology. The PARITY investigators were able to increase the recruitment levels throughout the trial and generally avoid trial fatigue. This was a North American based trial which may explain the longer start up times internationally given the different regulatory bodies associated with drug-related trials. However, international sites should be considered critical as they were able to recruit significantly more patients per month once active. The absence of research support personnel should not preclude a site from inclusion. These sites took longer to setup but had no difference in monthly recruitment once active. This study will create a framework for identifying and targeting high yield sites for future randomized control trials within orthopaedic oncology to maximum recruitment and resource allocation. Data quality is another consideration that will be addressed in future analyses of the PARITY trial

Aims

Hand trauma, consisting of injuries to both the hand and the wrist, are a common injury seen worldwide. The global age-standardized incidence of hand trauma exceeds 179 per 100,000. Hand trauma may require surgical management and therefore result in significant costs to both healthcare systems and society. Surgical site infections (SSIs) are common following all surgical interventions, and within hand surgery the risk of SSI is at least 5%. SSI following hand trauma surgery results in significant costs to healthcare systems with estimations of over £450 per patient. The World Health Organization (WHO) have produced international guidelines to help prevent SSIs. However, it is unclear what variability exists in the adherence to these guidelines within hand trauma. The aim is to assess compliance to the WHO global guidelines in prevention of SSI in hand trauma.

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The aim of this study was to describe and compare joint-specific and generic health-related quality of life outcomes of the first versus second knee in patients undergoing staged bilateral total knee arthroplasty (BTKA) for osteoarthritis.

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Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures.

Aims

Impaired fracture repair in patients with type 2 diabetes mellitus (T2DM) is not fully understood. In this study, we aimed to characterize the local changes in gene expression (GE) associated with diabetic fracture. We used an unbiased approach to compare GE in the fracture callus of Zucker diabetic fatty (ZDF) rats relative to wild-type (WT) littermates at three weeks following femoral osteotomy.

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We compared the risks of re-revision and mortality between two-stage and single-stage revision surgeries among patients with infected primary hip arthroplasty.

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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 metabolic variations between the cartilage of osteoarthritis (OA) and Kashin-Beck disease (KBD) remain largely unknown. Our study aimed to address this by conducting a comparative analysis of the metabolic profiles present in the cartilage of KBD and OA.

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The purpose of this study was to compare reoperation and revision rates of double plating (DP), single plating using a lateral locking plate (SP), or distal femoral arthroplasty (DFA) for the treatment of periprosthetic distal femur fractures (PDFFs).

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This study examined the relationship between obesity (OB) and osteoporosis (OP), aiming to identify shared genetic markers and molecular mechanisms to facilitate the development of therapies that target both conditions simultaneously.