Cite this article: Bone Joint Res 2023;12(6):372–374.

Objectives. The objective of this study was to perform a meta-analysis of all randomised controlled trials (RCTs) comparing surgical and non-surgical management of fractures of the proximal humerus, and to determine whether further analyses based on complexity of fracture, or the type of surgical intervention, produced disparate findings on patient outcomes. Methods. A systematic review of the literature was performed identifying all RCTs that compared surgical and non-surgical management of fractures of the proximal humerus. Meta-analysis of clinical outcomes was performed where possible. Subgroup analysis based on the type of fracture, and a sensitivity analysis based on the type of surgical intervention, were also performed. Results. Seven studies including 528 patients were included. The overall meta-analysis found that there was no difference in clinical outcomes. However, subgroup and sensitivity analyses found improved patient outcomes for more complex fractures managed surgically. Four-part fractures that underwent surgery had improved long-term health utility scores (mean difference, MD 95% CI 0.04 to 0.28; p = 0.007). They were also less likely to result in osteoarthritis, osteonecrosis and non/malunion (OR 7.38, 95% CI 1.97 to 27.60; p = 0.003). Another significant subgroup finding was that secondary surgery was more common for patients that underwent internal fixation compared with conservative management within the studies with predominantly three-part fractures (OR 0.15, 95% CI 0.04 to 0.63; p = 0.009). Conclusion. This meta-analysis has demonstrated that differences in the type of fracture and surgical treatment result in outcomes that are distinct from those generated from analysis of all types of fracture and surgical treatments grouped together. This has important implications for clinical decision making and should highlight the need for future trials to adopt more specific inclusion criteria. Cite this article: S. Sabharwal, N. K. Patel, D. Griffiths, T. Athanasiou, C. M. Gupte, P. Reilly. Trials based on specific fracture configuration and surgical procedures likely to be more relevant for decision making in the management of fractures of the proximal humerus: Findings of a meta-analysisBone Joint Res 2016;5:470–480. DOI: 10.1302/2046-3758.510.2000638

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

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies. Cite this article: Bone Joint J 2024;106-B(2):114–120

Aims. Children with spinal dysraphism can develop various musculoskeletal deformities, necessitating a range of orthopaedic interventions, causing significant morbidity, and making considerable demands on resources. This systematic review aimed to identify what outcome measures have been reported in the literature for children with spinal dysraphism who undergo orthopaedic interventions involving the lower limbs. Methods. A PROSPERO-registered systematic literature review was performed following PRISMA guidelines. All relevant studies published until January 2023 were identified. Individual outcomes and outcome measurement tools were extracted verbatim. The measurement tools were assessed for reliability and validity, and all outcomes were grouped according to the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT) filters. Results. From 91 eligible studies, 27 individual outcomes were identified, including those related to clinical assessment (n = 12), mobility (n = 4), adverse events (n = 6), investigations (n = 4), and miscellaneous (n = 1). Ten outcome measurement tools were identified, of which Hoffer’s Functional Ambulation Scale was the most commonly used. Several studies used unvalidated measurement tools originally developed for other conditions, and 26 studies developed new measurement tools. On the OMERACT filter, most outcomes reported pathophysiology and/or the impact on life. There were only six patient- or parent-reported outcomes, and none assessed the quality of life. Conclusion. The outcomes that were reported were heterogenous, lack validation and failed to incorporate patient or family perceptions. Until outcomes can be reported unequivocally, research in this area will remain limited. Our findings should guide the development of a core outcome set, which will allow consistency in the reporting of outcomes for this condition. Cite this article: Bone Joint J 2024;106-B(3):277–285

Aims. Orthopaedic surgery requires grafts with sufficient mechanical strength. For this purpose, decellularized tissue is an available option that lacks the complications of autologous tissue. However, it is not widely used in orthopaedic surgeries. This study investigated clinical trials of the use of decellularized tissue grafts in orthopaedic surgery. Methods. Using the ClinicalTrials.gov (CTG) and the International Clinical Trials Registry Platform (ICTRP) databases, we comprehensively surveyed clinical trials of decellularized tissue use in orthopaedic surgeries registered before 1 September 2022. We evaluated the clinical results, tissue processing methods, and commercial availability of the identified products using academic literature databases and manufacturers’ websites. Results. We initially identified 4,402 clinical trials, 27 of which were eligible for inclusion and analysis, including nine shoulder surgery trials, eight knee surgery trials, two ankle surgery trials, two hand surgery trials, and six peripheral nerve graft trials. Nine of the trials were completed. We identified only one product that will be commercially available for use in knee surgery with significant mechanical load resistance. Peracetic acid and gamma irradiation were frequently used for sterilization. Conclusion. Despite the demand for decellularized tissue, few decellularized tissue products are currently commercially available, particularly for the knee joint. To be viable in orthopaedic surgery, decellularized tissue must exhibit biocompatibility and mechanical strength, and these requirements are challenging for the clinical application of decellularized tissue. However, the variety of available decellularized products has recently increased. Therefore, decellularized grafts may become a promising option in orthopaedic surgery. Cite this article: Bone Joint Res 2023;12(3):179–188

Aims. The aim of this study was to evaluate the suitability, against an accepted international standard, of a linked hip fracture registry and routinely collected administrative dataset in England to embed and deliver randomized controlled trials (RCTs). Methods. First, a bespoke cohort of individuals sustaining hip fractures between 2011 and 2016 was generated from the National Hip Fracture Database (NHFD) and linked to individual Hospital Episode Statistics (HES) records and mortality data. Second, in order to explore the availability and distribution of outcomes available in linked HES-Office of National Statistics (ONS) data, a more contemporary cohort with incident hip fracture was identified within HES between January 2014 and December 2018. Distributions of the outcomes within the HES-ONS dataset were reported using standard statistical summaries; descriptive characteristics of the NHFD and linked HES-ONS dataset were reported in line with the Clinical Trials Transformation Initiative recommendations for registry-enabled trials. Results. Case ascertainment of the NHFD likely exceeds 94%. The assessment of the robustness, relevance, and reliability of the datasets was favourable. Outcomes from the HES-ONS dataset were concordant with other contemporaneous prospective cohort studies with bespoke data collection frameworks. Conclusion. Our findings support the feasibility of the NHFD and HES-ONS to support a registry-embedded, data-enabled RCT. Cite this article: Bone Joint J 2025;107-B(2):229–238

Aims. Machine learning (ML) holds significant promise in optimizing various aspects of total shoulder arthroplasty (TSA), potentially improving patient outcomes and enhancing surgical decision-making. The aim of this systematic review was to identify ML algorithms and evaluate their effectiveness, including those for predicting clinical outcomes and those used in image analysis. Methods. We searched the PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases for studies applying ML algorithms in TSA. The analysis focused on dataset characteristics, relevant subspecialties, specific ML algorithms used, and their performance outcomes. Results. Following the final screening process, 25 articles satisfied the eligibility criteria for our review. Of these, 60% focused on tabular data while the remaining 40% analyzed image data. Among them, 16 studies were dedicated to developing new models and nine used transfer learning to leverage existing pretrained models. Additionally, three of these models underwent external validation to confirm their reliability and effectiveness. Conclusion. ML algorithms used in TSA demonstrated fair to good performance, as evidenced by the reported metrics. Integrating these models into daily clinical practice could revolutionize TSA, enhancing both surgical precision and patient outcome predictions. Despite their potential, the lack of transparency and generalizability in many current models poses a significant challenge, limiting their clinical utility. Future research should prioritize addressing these limitations to truly propel the field forward and maximize the benefits of ML in enhancing patient care. Cite this article: Bone Jt Open 2025;6(2):126–134

Aims. Tobacco, in addition to being one of the greatest public health threats facing our world, is believed to have deleterious effects on bone metabolism and especially on bone healing. It has been described in the literature that patients who smoke are approximately twice as likely to develop a nonunion following a non-specific bone fracture. For clavicle fractures, this risk is unclear, as is the impact that such a complication might have on the initial management of these fractures. Methods. A systematic review and meta-analysis were performed for conservatively treated displaced midshaft clavicle fractures. Embase, PubMed, and Cochrane Central Register of Controlled Trials (via Cochrane Library) were searched from inception to 12 May 2022, with supplementary searches in Open Grey, ClinicalTrials.gov, ProQuest Dissertations & Theses, and Google Scholar. The searches were performed without limits for publication date or languages. Results. The meta-analysis included eight studies, 2,285 observations, and 304 events (nonunion). The random effects model predicted a pooled risk ratio (RR) of 3.68 (95% confidence interval 1.87 to 7.23), which can be considered significant (p = 0.003). It indicates that smoking more than triples the risk of nonunion when a fracture is treated conservatively. Conclusion. Smoking confers a RR of 3.68 for developing a nonunion in patients with a displaced middle third clavicle fracture treated conservatively. We know that most patients with pseudarthrosis will have pain and a poor functional outcome. Therefore, patients should be informed of the significantly higher risks of nonunion and offered smoking cessation efforts and counselling. Moreover, surgery should be considered for any patient who smokes with this type of fracture. Cite this article: Bone Joint J 2023;105-B(7):801–807

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. Methods. This will be an international, multicentre audit comparing antimicrobial practices in hand trauma to the standards outlined by WHO. Through the Reconstructive Surgery Trials Network (RSTN), hand surgeons across the globe will be invited to participate in the study. Consultant surgeons/associate specialists managing hand trauma and members of the multidisciplinary team will be identified at participating sites. Teams will be asked to collect data prospectively on a minimum of 20 consecutive patients. The audit will run for eight months. Data collected will include injury details, initial management, hand trauma team management, operation details, postoperative care, and antimicrobial techniques used throughout. Adherence to WHO global guidelines for SSI will be summarized using descriptive statistics across each criteria. Discussion. The Hand and Wrist trauma: Antimicrobials and Infection Audit of Clinical Practice (HAWAII ACP) will provide an understanding of the current antimicrobial practice in hand trauma surgery. This will then provide a basis to guide further research in the field. The findings of this study will be disseminated via conference presentations and a peer-reviewed publication. Cite this article: Bone Jt Open 2024;5(4):361–366

Aims. This study aimed to evaluate the effectiveness of the induced membrane technique for treating infected bone defects, and to explore the factors that might affect patient outcomes. Methods. A comprehensive search was performed in PubMed, Embase, and the Cochrane Central Register of Controlled Trials databases between 1 January 2000 and 31 October 2021. Studies with a minimum sample size of five patients with infected bone defects treated with the induced membrane technique were included. Factors associated with nonunion, infection recurrence, and additional procedures were identified using logistic regression analysis on individual patient data. Results. After the screening, 44 studies were included with 1,079 patients and 1,083 segments of infected bone defects treated with the induced membrane technique. The mean defect size was 6.8 cm (0.5 to 30). After the index second stage procedure, 85% (797/942) of segments achieved union, and 92% (999/1,083) of segments achieved final healing. The multivariate analysis with data from 296 patients suggested that older age was associated with higher nonunion risk. Patients with external fixation in the second stage had a significantly higher risk of developing nonunion, increasing the need for additional procedures. The autografts harvested from the femur reamer-irrigator-aspirator increased nonunion, infection recurrence, and additional procedure rates. Conclusion. The induced membrane technique is an effective technique for treating infected bone defects. Internal fixation during the second stage might effectively promote bone healing and reduce additional procedures without increasing infection recurrence. Future studies should standardize individual patient data prospectively to facilitate research on the affected patient outcomes. Cite this article: Bone Joint Res 2023;12(9):546–558

Aims. Prevalence of artificial intelligence (AI) algorithms within the Trauma & Orthopaedics (T&O) literature has greatly increased over the last ten years. One increasingly explored aspect of AI is the automated interpretation of free-text data often prevalent in electronic medical records (known as natural language processing (NLP)). We set out to review the current evidence for applications of NLP methodology in T&O, including assessment of study design and reporting. Methods. MEDLINE, Allied and Complementary Medicine (AMED), Excerpta Medica Database (EMBASE), and Cochrane Central Register of Controlled Trials (CENTRAL) were screened for studies pertaining to NLP in T&O from database inception to 31 December 2023. An additional grey literature search was performed. NLP quality assessment followed the criteria outlined by Farrow et al in 2021 with two independent reviewers (classification as absent, incomplete, or complete). Reporting was performed according to the Synthesis-Without Meta-Analysis (SWiM) guidelines. The review protocol was registered on the Prospective Register of Systematic Reviews (PROSPERO; registration no. CRD42022291714). Results. The final review included 31 articles (published between 2012 and 2021). The most common subspeciality areas included trauma, arthroplasty, and spine; 13% (4/31) related to online reviews/social media, 42% (13/31) to clinical notes/operation notes, 42% (13/31) to radiology reports, and 3% (1/31) to systematic review. According to the reporting criteria, 16% (5/31) were considered good quality, 74% (23/31) average quality, and 6% (2/31) poor quality. The most commonly absent reporting criteria were evaluation of missing data (26/31), sample size calculation (31/31), and external validation of the study results (29/31 papers). Code and data availability were also poorly documented in most studies. Conclusion. Application of NLP is becoming increasingly common in T&O; however, published article quality is mixed, with few high-quality studies. There are key consistent deficiencies in published work relating to NLP which ultimately influence the potential for clinical application. Open science is an important part of research transparency that should be encouraged in NLP algorithm development and reporting. Cite this article: Bone Jt Open 2025;6(3):264–274

Aims. The aim of this study is to define a core outcome set (COS) to allow consistency in outcome reporting amongst studies investigating the management of orthopaedic treatment in children with spinal dysraphism (SD). Methods. Relevant outcomes will be identified in a four-stage process from both the literature and key stakeholders (patients, their families, and clinical professionals). Previous outcomes used in clinical studies will be identified through a systematic review of the literature, and each outcome will be assigned to one of the five core areas, defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). Additional possible outcomes will be identified through consultation with patients affected by SD and their families. Results. Outcomes identified in these stages will be included in a two-round Delphi process that will involve key stakeholders in the management of SD. A final list including the identified outcomes will then be summarized in a consensus meeting attended by representatives of the key stakeholders groups. Conclusion. The best approach to provision of orthopaedic care in patients with SD is yet to be decided. The reporting of different outcomes to define success among studies, often based on personal preferences and local culture, has made it difficult to compare the effect of treatments for this condition. The development of a COS for orthopaedic management in SD will enable meaningful reporting and facilitate comparisons in future clinical trials, thereby assisting complex decision-making in the clinical management of these children. Cite this article: Bone Jt Open 2022;3(1):54–60

Aims. This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. Methods. MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder. Results. Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero. Conclusion. The findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open 2021;2(9):773–784

Aims. This systematic review and meta-analysis was conducted to compare open reduction and internal fixation (ORIF) with primary arthrodesis (PA) in the treatment of Lisfranc injuries, regarding patient-reported outcome measures (PROMs), and risk of secondary surgery. The aim was to conclusively determine the best available treatment based on the most complete and recent evidence available. Methods. A systematic search was conducted in PubMed, Cochrane Controlled Register of Trials (CENTRAL), EMBASE, CINAHL, PEDro, and SPORTDiscus. Additionally, ongoing trial registers and reference lists of included articles were screened. Risk of bias (RoB) and level of evidence were assessed using the Cochrane risk of bias tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. The random and fixed-effect models were used for the statistical analysis. Results. A total of 20 studies were selected for this review, of which 12 were comparative studies fit for meta-analysis, including three randomized controlled trials (RCTs). This resulted in a total analyzed population of 392 patients treated with ORIF and 249 patients treated with PA. The mean differences between the two groups in American Orthopedic Foot and Ankle Society (AOFAS), VAS, and SF-36 scores were -7.41 (95% confidence interval (CI) -13.31 to -1.51), 0.77 (95% CI -0.85 to 2.39), and -1.20 (95% CI -3.86 to 1.46), respectively. Conclusion. This is the first study to find a statistically significant difference in PROMs, as measured by the AOFAS score, in favour of PA for the treatment of Lisfranc injuries. However, this difference may not be clinically relevant, and therefore drawing a definitive conclusion requires confirmation by a large prospective high-quality RCT. Such a study should also assess cost-effectiveness, as cost considerations might be decisive in decision-making. Level of Evidence: I. Cite this article: Bone Jt Open 2021;2(10):842–849

Aims. Metal allergy in knee arthroplasty patients is a controversial topic. We aimed to conduct a scoping review to clarify the management of metal allergy in primary and revision total knee arthroplasty (TKA). Methods. Studies were identified by searching electronic databases: Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Embase, from their inception to November 2020, for studies evaluating TKA patients with metal hypersensitivity/allergy. All studies reporting on diagnosing or managing metal hypersensitivity in TKA were included. Data were extracted and summarized based on study design, study population, interventions and outcomes. A practical guide is then formulated based on the available evidence. Results. We included 38 heterogeneous studies (two randomized controlled trials, six comparative studies, 19 case series, and 11 case reports). The evidence indicates that metal hypersensitivity is a rare complication with some histopathological features leading to pain and dissatisfaction with no reliable screening tests preoperatively. Hypoallergenic implants are viable alternatives for patients with self-reported/confirmed metal hypersensitivity if declared preoperatively; however, concerns remain over their long-term outcomes with ceramic implants outperforming titanium nitride-coated implants and informed consent is paramount. For patients presenting with painful TKA, metal hypersensitivity is a diagnosis of exclusion where patch skin testing, lymphocyte transformation test, and synovial biopsies are useful adjuncts before revision surgery is undertaken to hypoallergenic implants with shared decision-making and informed consent. Conclusion. Using the limited available evidence in the literature, we provide a practical approach to metal hypersensitivity in TKA patients. Future national/registry-based studies are needed to identify the scale of metal hypersensitivity, agreed diagnostic criteria, and management strategies. Cite this article: Bone Jt Open 2021;2(10):785–795

Aims. To analyze outcomes reported in studies of Ponseti correction of idiopathic clubfoot. Methods. A systematic review of the literature was performed to identify a list of outcomes and outcome tools reported in the literature. A total of 865 studies were screened following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and 124 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Each outcome tool was assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). Bias assessment was not deemed necessary for the purpose of this paper. Results. In total, 20 isolated outcomes and 16 outcome tools were identified representing five OMERACT domains. Most outcome tools were appropriately designed for children of walking age but have not been embraced in the literature. The most commonly reported isolated outcomes are subjective and qualitative. The quantitative outcomes most commonly used are ankle range of motion (ROM), foot position in standing, and muscle function. Conclusions. There is a diverse range of outcomes reported in studies of Ponseti correction of clubfoot. Until outcomes can be reported unequivocally and consistently, research in this area will be limited. Completing the process of establishing and validating COS is the much-needed next step. Cite this article: Bone Joint Open 2020;1-8:457–464