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IntroductionDespite their exponential use, intra-articular (IA) injections of platelet-rich plasma (PRP) are not part of the recommended treatments for knee osteoarthritis (OA) by most international scientific societies. The most recent clinical trials have shown conflicting results, and some did not find any clinical benefit of PRP injections. The PRP In Knee OsteoArthritis (PIKOA) trial was designed to assess the clinical efficacy and structural benefit of IA injections of PRP vs saline solution (placebo) in symptomatic knee OA.Methods and analysisPIKOA is an academic phase 3, superiority, triple-blind (patients, investigators and injectors), multicentre, randomised placebo-controlled trial (1:1 ratio). It compares the efficacy of 1 weekly IA injection of 5 mL PRP or placebo (saline solution) for 3 weeks with a 6-month follow-up. The trial will enrol 210 participants ≥40 years old with symptomatic and moderate radiographic knee OA (Kellgren and Lawrence grade 2 or 3). PRP is prepared with the A-CP-Kit-T (20 mL) kit and its cellular composition is characterised for each patient. The main objective is to compare change in pain on a 0 mm to 100 mm visual analogue scale (VAS) between W0 and W14. The secondary objectives are to compare the two groups in terms of decrease in VAS pain, Western Ontario and McMaster Universities Osteoarthritis Index total score and subscores, analgesics consumption, OMERACT-Osteoarthritis Research Society International responder rate and improvement in quality of life measured by the EQ-5D-5L score. All these criteria are assessed at W8, W14 and W26. The decrease in serum Coll2-1 and Coll2-1 NO₂ levels (catabolic markers, reflecting cartilage destruction or joint inflammation) and increase in N-propeptide of cartilage IIA level (reflecting cartilage formation) are assessed at W8 and W14. Adverse events and study withdrawals are collected during the study.Ethics and disseminationEthics approval was obtained from the Nord Ouest ethical committee (2021-A00742-39). All participants need to provide written informed consent. The findings will be published in peer-reviewed journals.Trial registration numberNCT05378815 (ClinicalTrials.gov); pre-results.Protocol version and number: V.3 of 17 July 2023.

IntroductionAlthough ultrasound can reportedly diagnose discoid lateral meniscus (DLM) in children, its widespread application is challenging because the diagnostic criteria are based on qualitative descriptions of DLM morphology rather than quantitative parameters. Additionally, no studies have applied ultrasound in classifying DLM. Therefore, this study aims to establish the quantitative ultrasound parameters that reflect DLM morphology, evaluate the feasibility and validity of these parameters for identifying DLM and their classification, and develop the quantitative ultrasound diagnostic criteria for DLM and their classification in children.Methods and analysisPatients will be recruited from the outpatient clinics of the orthopaedics department at West China Hospital, Sichuan University, the Fourth Medical Center of the Chinese People’s Liberation Army General Hospital, Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Yibin Hospital affiliated with West China Hospital Sichuan University, Suining Central Hospital and the Third Hospital of Mianyang from August 2022 to July 2024. Eligible patients are those aged ≤14 years, with knee symptoms such as pain, locking and limited extension, and who planned to undergo arthroscopic surgery. Exclusion criteria are patients with contraindications to ultrasound examination, such as severe skin damage or fracture around the knee. The sample size is estimated to be 576 cases with a power of 0.9 for hypothesis testing, a two-sided α of 0.05, and an expected sensitivity and specificity of 95%. Three days before surgery, ultrasound will be used to observe the morphology of the lateral meniscus and measure its width, angle α formed by the chord of upper and lower arc-shaped articular surface at the free edge, and the movement distance of the peripheral rim. Participants will be categorised according to the arthroscopy results for the DLM and its classification. The diagnostic performance of each parameter will be assessed and compared in terms of the area under the curve, sensitivity, specificity, and positive and negative predictive values.Ethics and disseminationThis study was approved by the Ethics Committee of West China Hospital, Sichuan University (approval no. 2022-923), and this approval covers all study hospitals. Written informed consent is required from all participants before enrolment in the study. The study’s findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberChinese Clinical Trial Registry (ChiCTR2200062000).

IntroductionDistal radius is the most common site of fracture in children, comprising 23%–31% of all paediatric fractures. Approximately one-fifth of these fractures are displaced. Completely displaced distal metaphyseal radius fractures in children have traditionally been treated with closed reduction. Recent evidence suggests that correcting the shortening in over-riding distal metaphyseal radius fractures is not necessary in prepubertal children. To date, no published randomised controlled trial (RCT) has compared treatment of these fractures in children by casting the fracture in bayonet position to reduction and pin fixation.Methods and analysisWe will conduct an RCT to compare the outcomes of casting the fracture in bayonet position in children under 11 years of age to reduction and percutaneous pin fixation. 60 patients will be randomly assigned to casting or surgery groups. We have two primary outcomes. The first is ratio (injured side/non-injured side) in the total active forearm rotation and the second is ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion–extension plane at 6 months. The secondary outcomes will include axial radiographic alignment, passive extension of the wrists, grip strength and length of forearms and hands, patient-reported outcome QuickDASH and pain questionnaire PedsQL. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort. Patients not eligible for randomisation will be asked to participate in a non-eligible cohort. These cohorts are included to enhance the external validity of the results of the RCT. Our null hypothesis is that the results of the primary outcome measures in the casting group are non-inferior to surgery group.Ethics and disseminationThe institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications.Trial registration numberNCT04323410.ProtocolV.1.1, 29 September 2020.

ObjectivesTo evaluate the most up-to-date burden of traumatic brain injury (TBI) and spinal cord injury (SCI) and analyse their leading causes in different countries/territories.DesignAn analysis of Global Burden of Disease (GBD) data.SettingThe epidemiological data were gathered from GBD Results Tool (1 January, 1990─31 December 2019) covering 21 GBD regions and 204 countries/ territories.ParticipantsPatients with TBI/SCI.Main outcomes and measuresAbsolute numbers and age-standardised rates/estimates of incidence, prevalence and years lived with disability (YLDs) of TBI/SCI by location in 2019, with their percentage changes from 1990 to 2019. The leading causes (eg, falls) of TBI/SCI in 204 countries/territories.ResultsGlobally, in 2019, TBI had 27.16 million new cases, 48.99 million prevalent cases and 7.08 million YLDs. SCI had 0.91 million new cases, 20.64 million prevalent cases and 6.20 million YLDs. Global age-standardised incidence rates of TBI decreased significantly by −5.5% (95% uncertainty interval −8.9% to −3.0%) from 1990 to 2019, whereas SCI had no significant change (−6.1% (−17.3% to 1.5%)). Regionally, in 2019, Eastern Europe and High-income North America had the highest burden of TBI and SCI, respectively. Nationally, in 2019, Slovenia and Afghanistan had the highest age-standardised incidence rates of TBI and SCI, respectively. For TBI, falls were the leading cause in 74% (150/204) of countries/territories, followed by pedestrian road injuries (14%, 29/204), motor vehicle road injuries (5%, 11/204), and conflict and terrorism (2%, 4/204). For SCI, falls were the leading cause in 97% (198/204) of countries/territories, followed by conflict and terrorism (3%, 6/204).ConclusionsGlobal age-standardised incidence rates of TBI have decreased significantly since 1990, whereas SCI had no significant change. The leading causes of TBI/SCI globally were falls, but variations did exist between countries/territories. Policy-makers should continue to prioritise interventions to reduce falls, but priorities may vary between countries/territories.

IntroductionThis study is designed to explore the baseline characteristics of patients under 55 years of age with a meniscal tear, and to describe the relationship between the baseline characteristics and patient-reported outcome measures (PROMs) over 12 months. Research has highlighted the need for a trial to investigate the effectiveness of arthroscopic meniscectomy in younger patients. Before this trial, we need to understand the patient population in greater detail.Methods and analysisThis is a multicentre prospective cohort study. Participants aged between 18 and 55 years with an MRI confirmed meniscal tear are eligible for inclusion. Baseline characteristics including age, body mass index, gender, PROMs duration of symptoms and MRI will be collected. The primary outcome measure is the Western Ontario Meniscal Evaluation Tool at 12 months. Secondary outcome measures will include PROMs such as EQ5D, Knee Injury and Osteoarthritis Outcome Score and patient global impression of change score at 3, 6 and 12 months.Ethics and disseminationThe study obtained approval from the National Research Ethics Committee West Midlands—Black Country research ethics committee (19/WM/0079) on 12 April 2019. The study is sponsored by the University of Warwick. The results will be disseminated via peer-reviewed publication.Trial registration numberUHCW R&D Reference: IA428119. University of Warwick Sponsor ID: SC.08/18–19

IntroductionThe quantity and quality of surgical training in the UK has been negatively affected by reduced working hours and National Health Service (NHS) financial pressures. Traditionally surgical training has occurred by the master-apprentice model involving a process of graduated responsibility, but a modern alternative is to use simulation for the early stages of training. It is not known if simulation training for junior trainees can safeguard patients and improve clinical outcomes. This paper details the protocol for a multicentre randomised controlled educational trial of a cadaveric simulation training intervention versus standard training for junior postgraduate orthopaedic surgeons-in-training. This is the first study to assess the effect of cadaveric simulation training for open surgery on patient outcome. The feasibility of delivering cadaveric training, use of radiographic and clinical outcome measures to assess impact and the challenges of upscaling provision will be explored.Methods and analysisWe will recruit postgraduate orthopaedic surgeons-in-training in the first 3 years (of 8) of the specialist training programme. Participants will be block randomised and allocated to either cadaveric simulation or standard ‘on-the-job’ training, learning three common orthopaedic procedures, each of which is a substudy within the trial. The procedures are (1) dynamic hip screw, (2) hemiarthroplasty and (3) ankle fracture fixation. These procedures have been selected as they are very common procedures which are routinely performed by junior surgeons-in-training. A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. The primary outcome measure is the technical success of the surgery performed on patients by the participating surgeons-in-training during the follow-up period for the three substudy procedures, as measured by the implant position on the postoperative radiograph. The secondary outcome measures are procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D—substudies 1 and 2 only).Ethics, registration and disseminationNational research ethics approval was granted for this study by the NHS Research Authority South Birmingham Research Ethics Committee (15/WM/0464). Confidentiality Advisory Group approval was granted for accessing radiographic and outcome data without patient consent on 27 February 2017 (16/CAG/0125). The results of this trial will be submitted to a peer-reviewed journal and will inform educational and clinical practice.Trial registration numberISRCTN20431944

BackgroundNew surgical approaches have been developed to optimise elbow function after total elbow arthroplasty (TEA). Currently, there is no consensus on the best surgical approach. This study aims to investigate the functional outcomes, prosthetic component position and complication rates after a triceps-sparing and a triceps-detaching approach in TEA.Methods and analysisA multicentre prospective comparative cohort study will be conducted. All patients with an indication for primary TEA will enrol in either the triceps-sparing or the triceps-detaching cohort. Primary outcome measure is elbow function, specified as fixed flexion deformity. Secondary outcome parameters are self-reported and objectively measured physical functioning, including triceps force, prosthetic component position in standard radiographs and complications.DiscussionThe successful completion of this study will clarify which surgical approach yields better functional outcomes, better prosthetic component position and lower complication rates in patients with a TEA.Ethics and disseminationThe Medical Ethics Review Board of University Medical Center Groningen reviewed the study and concluded that it is not clinical research with human subjects as meant in the Medical Research Involving Human Subjects Act (WMO), therefore WMO approval is not needed (METc2019/544).Trial registration numberNTR NL8488.

IntroductionPaediatric major trauma patients with more severe injuries and physiological or biochemical abnormalities as a result of the injury are more likely to require invasive management in the form of an operation/interventional radiology (IR). Adverse psychological outcomes, such as post-traumatic stress disorder, anxiety, depression and adjustment disorder, are frequently observed in paediatric patients with major trauma. Similarly, it is recognised that children and adolescents who have invasive management are also at an increased risk of adverse psychological outcomes. However, it is not known to what extent major trauma patients requiring invasive management are at risk of adverse psychological outcomes compared with those managed conservatively. This study aims to determine whether paediatric major trauma patients who require an operation/IR have increased odds of having an adverse psychological outcome compared with those who are managed conservatively.Methods and analysisThe Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines will be used to construct this review. The databases Medline (via Ovid), Embase (via Ovid), PsycInfo (via Ebscohost) and Cinahl (via Ebscohost) will be searched from inception to February 2025. Both title and abstract screening and full-text screening will be done by two reviewers, with an adjudicating third reviewer. For randomised controlled trials, the Cochrane Risk of Bias Tool will be employed, while for non-randomised studies, the Newcastle-Ottawa Quality Assessment Scale will be used. We will assess bias using contoured funnel plots (with p set at 0.01, 0.05 and 0.10), non-parametric trim-fill analysis, leave-one-out analysis and Galbraith plotting. We will execute formal (Egger) testing for funnel plot asymmetry and also calculate prediction intervals if sufficient study N of 10 is accrued. Certainty and confidence in cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.Ethics and disseminationEthical review is not required as no original data will be collected. Results will be disseminated through peer-reviewed publications and at academic conferences.PROSPERO registration numberCRD42025643459.

BackgroundStudies from different Western countries have reported a rapid increase in spinal surgery rates, an increase that exceeds by far the growing incidence rates of spinal disorders in the general population. There are few studies covering all lumbar spine surgery and no previous studies from Norway.ObjectivesThe purpose of this study was to investigate trends in all lumbar spine surgery in Norway over 15 years, including length of hospital stay, and rates of complications and reoperations.DesignA longitudinal observational study over 15 years using hospital patient administrative data and sociodemographic data from the National Registry in Norway.Setting and participantsPatients aged ≥18 years discharged from Norwegian public hospitals between 1999 and 2013.Outcome measuresAnnual rates of simple (microsurgical discectomy, decompression) and complex surgical procedures (fusion, disc prosthesis) in the lumbar spine.ResultsThe rate of lumbar spine surgery increased by 54%, from 78 (95% CI (75 to 80)) to 120 (107 to 113) per 100 000, from 1999 to 2013. More men had simple surgery whereas more women had complex surgery. Among elderly people over 75 years, lumbar surgery increased by a factor of five during the 15-year period. The rates of complications were low, but increased from 0.7% in 1999 to 2.4% in 2013.ConclusionsThere was a substantial increase in lumbar spine surgery in Norway from 1999 to 2013, similar to trends in other Western world countries. The rise in lumbar surgery among elderly people represents a significant workload and challenge for health services, given our aging population.

ObjectiveTo determine the benefits and harms of pre-admission interventions (prehabilitation) on postoperative outcomes in patients undergoing major elective surgery.DesignSystematic review and meta-analysis of randomised controlled trials (RCTs) (published or unpublished). We searched Medline, Embase, CENTRAL, DARE, HTA and NHS EED, The Cochrane Library, CINAHL, PsychINFO and ISI Web of Science (June 2020).SettingSecondary care.ParticipantsPatients (≥18 years) undergoing major elective surgery (curative or palliative).InterventionsAny intervention administered in the preoperative period with the aim of improving postoperative outcomes.Outcomes and measuresPrimary outcomes were 30-day mortality, hospital length of stay (LoS) and postoperative complications. Secondary outcomes included LoS in intensive care unit or high dependency unit, perioperative morbidity, hospital readmission, postoperative pain, heath-related quality of life, outcomes specific to the intervention, intervention-specific adverse events and resource use.Review methodsTwo authors independently extracted data from eligible RCTs and assessed risk of bias and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation. Random-effects meta-analyses were used to pool data across trials.Results178 RCTs including eight types of intervention were included. Inspiratory muscle training (IMT), immunonutrition and multimodal interventions reduced hospital LoS (mean difference vs usual care: −1.81 days, 95% CI −2.31 to −1.31; −2.11 days, 95% CI −3.07 to −1.15; −1.67 days, 95% CI −2.31 to −1.03, respectively). Immunonutrition reduced infective complications (risk ratio (RR) 0.64 95% CI 0.40 to 1.01) and IMT, and exercise reduced postoperative pulmonary complications (RR 0.55, 95% CI 0.38 to 0.80, and RR 0.54, 95% CI 0.39 to 0.75, respectively). Smoking cessation interventions reduced wound infections (RR 0.28, 95% CI 0.12 to 0.64).ConclusionsSome prehabilitation interventions may reduce postoperative LoS and complications but the quality of the evidence was low.PROSPERO registration numberCRD42015019191.