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Arthroplasty registries: a valuable tool to orthopaedic surgeons, manufacturers, patients and regulators? 关节成形术登记:矫形外科医生、制造商、患者和监管机构的宝贵工具?
Q4 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.mporth.2024.03.001
Jasper G. Gerbers, Rob GHH. Nelissen

Historically, orthopaedic implants required little clinical evidence before market introduction, either in the USA or the European Union (EU). There have been major incidents, with faulty designs or manufacturing techniques resulting in patient harm. The new EU Medical Device Regulations (MDR) have significantly changed the requirements around the introduction to the market of new medical devices in the EU. Initiatives like CORE-MD are founded to improve this process. EUDAMED will provide a mandatory European implant safety register. Real-world data, such as implant registries, have a major role to play in the continuous monitoring of implants, but this depends on them having high completeness (>95%) as well as coverage. Registries can also be used for post-market surveillance. Although implant registries use endpoints such as revision, as well as patient-reported outcomes, long-term follow-up is still needed to detect mediocre implants. For new designs, this often takes too long and potentially exposes patients to mediocre implants. This can be prevented by using more accurate, highly predictive methods at early follow-up (at 1 year), such as implant migration studies. Furthermore, registry-based or nested randomized controlled trials can be used to evaluate new implant designs and surgical techniques. Monitoring implants through registries remains vital in order to detect early or late unexpected failures related to the implant, surgical technique or indication, enhancing both implant development as well as patient safety.

一直以来,无论是在美国还是欧盟(EU),骨科植入物在上市前几乎不需要临床证据。曾经发生过重大事故,错误的设计或制造技术导致患者受到伤害。新的欧盟医疗器械法规(MDR)大大改变了欧盟对新医疗器械上市的要求。像 CORE-MD 这样的倡议就是为了改善这一过程而设立的。EUDAMED 将提供一个强制性的欧洲植入安全登记册。真实世界的数据,如植入物登记册,在植入物的持续监控中发挥着重要作用,但这取决于它们是否具有较高的完整性(95%)和覆盖率。登记还可用于上市后监测。虽然植入物登记使用了翻修等终点指标以及患者报告的结果,但仍需要进行长期跟踪,以发现不良植入物。对于新设计而言,这往往需要太长时间,并有可能使患者接触到不良植入物。如果在早期随访(1 年)时使用更准确、预测性更强的方法,如植入体迁移研究,就可以避免这种情况的发生。此外,还可以通过登记或嵌套随机对照试验来评估新的种植体设计和手术技术。通过登记册对植入物进行监测对于发现与植入物、手术技术或适应症有关的早期或晚期意外故障,从而提高植入物的开发和患者的安全仍然至关重要。
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引用次数: 0
Human factors in trauma and orthopaedic surgery: a short overview 创伤和矫形外科中的人为因素:简要概述
Q4 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.mporth.2024.03.002
John A. Hardie, Peter A. Brennan

A human factors (HF) approach can help optimize individual and team performance in healthcare and across related professions that work together. Trauma and orthopaedic surgeons carry out high-stakes tasks within a cognitively and physically demanding environment. This is compounded by the challenges of working in complex healthcare systems. Error is a ‘normal’ part of being human, and must be managed in order to prevent harm to patients and staff. HF is the science of how people work within their teams, and in the workplace. It examines interactions with equipment, and the processes used to achieve the desired outcome. It uses theory from fields as diverse as ergonomics, psychology and engineering in order to achieve these aims. This article outlines key topics relevant to surgeons striving to help improve patient safety and wellbeing within teams. These include theories of error in healthcare, systems-based approaches, performance-limiting factors, and non-technical skills.

人为因素(HF)方法有助于优化医疗保健和相关行业中个人和团队的工作表现。创伤和矫形外科医生在认知和体力要求都很高的环境中执行高风险任务。在复杂的医疗保健系统中工作所面临的挑战更是雪上加霜。出错是人类的 "正常 "现象,必须加以控制,以防止对患者和员工造成伤害。高频是一门研究人们如何在团队和工作场所中工作的科学。它研究人与设备之间的互动,以及实现预期结果的过程。它采用人体工程学、心理学和工程学等不同领域的理论来实现这些目标。本文概述了与外科医生相关的关键主题,这些主题旨在帮助改善团队中的患者安全和福祉。其中包括医疗保健中的错误理论、基于系统的方法、绩效限制因素和非技术性技能。
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引用次数: 0
Management of haematogenous bone and joint infection in developing countries 发展中国家血源性骨与关节感染的管理
Q4 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.mporth.2024.03.005
Myung-Sang Moon

Haematogenous pyogenic bone and joint infection is rarely seen in developed countries, but in the developing world it is still a major and common problem. New forms of acute fulminating osteomyelitis are likely to appear due to immunosuppression in the wake of the worldwide spread of HIV infection, AIDS, and the increased use of steroids, antibiotics, and immune activators. Osteomyelitis due to candida and cryptococcus infection in certain regions, are occasionally observed, whilst osteomyelitis that is resistant to treatment is associated with diabetes mellitus. Bone and joint infections are difficult to cure. This difficulty is related to the presence of bacteria adherent to dead bone and foreign material in many cases, and also to the drug resistance and limited penetration of antibiotics into infected bone. This presentation summarizes present knowledge of bone and joint infection and its management.

血源性化脓性骨与关节感染在发达国家很少见,但在发展中国家仍是一个主要和常见的问题。由于艾滋病毒感染和艾滋病在全球蔓延,以及类固醇、抗生素和免疫激活剂的使用增加,免疫抑制可能会导致新形式的急性暴发性骨髓炎出现。在某些地区,偶尔会观察到由念珠菌和隐球菌感染引起的骨髓炎,而耐药性骨髓炎则与糖尿病有关。骨与关节感染很难治愈。这种困难与许多病例中死骨和异物上附着的细菌有关,也与抗生素的耐药性和对感染骨的渗透有限有关。本讲座总结了目前有关骨与关节感染及其治疗的知识。
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引用次数: 0
The Scottish Arthroplasty Project: Scotland's approach to a National Joint Registry 苏格兰关节成形术项目:苏格兰建立国家关节登记处的方法
Q4 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.mporth.2024.03.003
Justine Burt, Andrew Brunt, Andrew J. Hall, Jon V. Clarke, Phil Walmsley

The core function of joint registries is to collect, collate, and present data about patients who undergo joint replacement surgery, and afford clinicians and administrators a range of analytic functions to monitor service performance. This article describes the development, evolution, and future of arthroplasty registries, drawing particularly from the experience of the Scottish Arthroplasty Project (SAP). The SAP was established in 1999 and is one of the oldest arthroplasty registries in the world. It collects information on patients undergoing hip, knee, ankle, shoulder, and elbow arthroplasty. The primary aim is to encourage continual improvement in the quality of care provided for arthroplasty patients in Scotland. It is distinct in terms of administration and methodology from the National Joint Registry (NJR) of England, Wales, and Northern Ireland as it monitors patients rather than implants. Since its inception, its work has contributed to a reduction in overall complication rates and a significant decrease in hospital length of stay for the growing number of patients undergoing arthroplasty. It continues to provide a robust database that is used to underpin national guidance through data-driven research. The research carried out by dedicated SAP fellows has enhanced the research portfolio of the SAP and raised its profile through high quality peer-reviewed publications. The SAP continues to evolve and by collaborating with other Scottish registries it will provide larger datasets containing greater diversity and granularity of information. These developments as well as ongoing analysis of existing areas ensure that the SAP continues to maintain and improve standards in arthroplasty across Scotland.

关节登记处的核心功能是收集、整理和展示接受关节置换手术患者的数据,并为临床医生和管理人员提供一系列分析功能,以监控服务绩效。本文特别借鉴苏格兰关节成形术项目(SAP)的经验,介绍了关节成形术登记处的发展、演变和未来。苏格兰关节成形术项目成立于 1999 年,是世界上历史最悠久的关节成形术注册机构之一。它收集接受髋关节、膝关节、踝关节、肩关节和肘关节置换术患者的信息。其主要目的是鼓励不断提高苏格兰关节成形术患者的护理质量。它在管理和方法上有别于英格兰、威尔士和北爱尔兰的国家关节登记处(NJR),因为它监测的是患者而非植入物。自成立以来,它的工作为降低总体并发症发生率和显著缩短越来越多的关节置换术患者的住院时间做出了贡献。通过数据驱动的研究,该中心不断提供强大的数据库,为国家指导提供依据。由专门的 SAP 研究员开展的研究增强了 SAP 的研究组合,并通过高质量的同行评审出版物提高了其知名度。SAP 还在继续发展,通过与苏格兰其他登记处的合作,它将提供更大的数据集,包含更多样化和更精细的信息。这些发展以及对现有领域的持续分析确保了 SAP 能够继续保持并提高整个苏格兰的关节成形术标准。
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引用次数: 0
Skeletal muscle structure, function and pathology 骨骼肌结构、功能和病理
Q4 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.mporth.2024.03.004
James Allen, Mark Ramsden, Sohail Nisar

Skeletal muscle is an important structure responsible for producing movement, storing nutrients, maintaining posture and providing stability across joints. Unlike smooth and cardiac muscle, control can be voluntary. This review article will outline the macroscopic and microscopic appearance of skeletal muscle, the method by which it contracts, the types of skeletal muscle and pathology associated with it.

骨骼肌是一种重要的结构,负责产生运动、储存营养、保持姿势和提供关节稳定性。与平滑肌和心肌不同,骨骼肌的控制是自愿的。这篇综述文章将概述骨骼肌的宏观和微观外观、收缩方法、骨骼肌类型以及相关病理。
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引用次数: 0
Reducing morbidity and mortality in the hip fracture patient group 降低髋部骨折患者群体的发病率和死亡率
Q4 Medicine Pub Date : 2024-02-20 DOI: 10.1016/j.mporth.2024.01.004
Martyn J Parker

A review of the literature was undertaken to determine which amenable factors could be identified that would potentially improve the morbidity or mortality after hip fracture. Only four factors were identified that have been clearly reported to be associated with a reduction in mortality or morbidity, these were early surgery, cemented arthroplasty and experience of the surgeon and peri-operative antibiotics. Five interventions were identified that may reduce mortality or morbidity: nerve blocks, nutritional support, pharmacological thromboembolic prophylaxis, mechanical intermittent pneumatic compression and nail fixation of extracapsular fractures. Several other factors were identified for which it remains uncertain if they will reduce mortality or morbidity: preoperative assessment, β-blockers, blood transfusion, anti-embolism stockings, choice of surgical implant, cardiac output monitoring during surgery, choice of anaesthesia, prevention of intraoperative hypotension, anabolic steroids, multidisciplinary care, and rehabilitation. Continuing research is required to define which interventions are clearly effective and to further identify any adverse effects.

我们对文献进行了综述,以确定哪些可行的因素有可能改善髋部骨折后的发病率或死亡率。结果发现,只有四个因素被明确报道与死亡率或发病率的降低有关,它们是早期手术、骨水泥关节成形术、外科医生的经验以及围手术期抗生素。有五项干预措施可降低死亡率或发病率:神经阻滞、营养支持、药物血栓栓塞预防、机械性间歇气压和囊外骨折钉固定。还有一些因素能否降低死亡率或发病率尚不确定,如术前评估、β-受体阻滞剂、输血、抗栓塞袜、手术植入物的选择、手术过程中的心输出量监测、麻醉选择、术中低血压的预防、合成代谢类固醇、多学科护理和康复。需要继续开展研究,以确定哪些干预措施明显有效,并进一步确定任何不良影响。
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引用次数: 0
Sub-trochanteric femoral fractures: challenges and solutions 股骨转子下骨折:挑战与解决方案
Q4 Medicine Pub Date : 2024-02-20 DOI: 10.1016/j.mporth.2024.01.002
James Edward Dixon, Jun Wei Lim, Iain McWilliam Stevenson

Sub-trochanteric femoral fractures represent around 10–34% of proximal femoral fragility fractures. They are notoriously difficult to treat, particularly achieving and maintaining reduction, which in turn can lead to longer operative time, more blood loss and higher rates of non-union. This review article provides an update on the potential reasons why fixation of sub-trochanteric fractures may fail, which implants are available, and what techniques can be used to try to avoid failure. Key papers from 2016 onwards were reviewed to deliver an overview of complications, implant choice, reduction techniques and consequences of open reduction.

股骨转子下骨折约占股骨近端脆性骨折的10%-34%。股骨转子下骨折是出了名的难治病,尤其是在实现和维持复位方面,这反过来又会导致手术时间延长、失血增多和不愈合率升高。这篇综述文章介绍了转子下骨折固定失败的潜在原因、可用的植入物以及可用于避免失败的技术。文章回顾了 2016 年以来的主要论文,概述了并发症、植入物选择、复位技术和切开复位的后果。
{"title":"Sub-trochanteric femoral fractures: challenges and solutions","authors":"James Edward Dixon,&nbsp;Jun Wei Lim,&nbsp;Iain McWilliam Stevenson","doi":"10.1016/j.mporth.2024.01.002","DOIUrl":"https://doi.org/10.1016/j.mporth.2024.01.002","url":null,"abstract":"<div><p>Sub-trochanteric femoral fractures represent around 10–34% of proximal femoral fragility fractures. They are notoriously difficult to treat, particularly achieving and maintaining reduction, which in turn can lead to longer operative time, more blood loss and higher rates of non-union. This review article provides an update on the potential reasons why fixation of sub-trochanteric fractures may fail, which implants are available, and what techniques can be used to try to avoid failure. Key papers from 2016 onwards were reviewed to deliver an overview of complications, implant choice, reduction techniques and consequences of open reduction.</p></div>","PeriodicalId":39547,"journal":{"name":"Orthopaedics and Trauma","volume":"38 2","pages":"Pages 78-84"},"PeriodicalIF":0.0,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140290443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What's new in the management of osteoporosis and prevention of fragility fractures? 骨质疏松症的治疗和脆性骨折的预防有何新进展?
Q4 Medicine Pub Date : 2024-02-20 DOI: 10.1016/j.mporth.2024.01.006
Gillian Fordyce, Rosemary Hollick, Alison Black

With an increasingly ageing population it has never been more important to reduce the burden of fragility fractures. Fragility fractures, especially those of spine and hip, affect an individual's morbidity and mortality and carry a significant economic burden. There has been a recent shift towards a more stratified approach to the management of fracture risk, using fracture assessment tools, in combination with assessment of bone mineral density using dual X-ray absorptiometry scanning. Primary and secondary fracture prevention will be outlined including the important role of fracture liaison services. The use of medications which reduce fracture risks are discussed including the use of zoledronate in the immediate post-hip fracture setting.

随着人口老龄化的加剧,减少脆性骨折的负担变得前所未有的重要。脆性骨折,尤其是脊柱和髋部骨折,会影响个人的发病率和死亡率,并带来巨大的经济负担。近来,骨折风险的管理已转向更加分层的方法,即使用骨折评估工具,结合使用双 X 射线吸收扫描评估骨矿密度。将概述骨折的一级和二级预防,包括骨折联络服务的重要作用。还将讨论降低骨折风险的药物使用,包括唑来膦酸钠在髋部骨折后立即使用的情况。
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引用次数: 0
The National Hip Fracture Database: lessons learned and future horizons 国家髋部骨折数据库:经验教训与未来展望
Q4 Medicine Pub Date : 2024-02-20 DOI: 10.1016/j.mporth.2024.01.007
Will Eardley, Antony Johansen

The effective management of older patients with fragility fractures of the femur remains central to modern trauma care. Processes of assessment and communication alongside means of identifying poor performance are vital to improving care in this population. The National Hip Fracture Database (NHFD) now contains around 1 million cases and has evolved over time to reflect contemporary practices in the care of older injured patients. The NHFD is in a unique position to inform hip fracture care and the wider global management of injured older patients. This report provides an update and details the processes within the NHFD, the scope, lessons learned and highlights future direction.

有效管理股骨脆性骨折老年患者仍然是现代创伤护理的核心。评估和沟通流程以及识别不良表现的方法对于改善这类人群的护理至关重要。国家髋部骨折数据库(NHFD)目前包含约 100 万个病例,并随着时间的推移不断发展,以反映老年伤员的现代护理实践。国家髋部骨折数据库在为髋部骨折护理和更广泛的全球老年受伤患者管理提供信息方面具有独特的地位。本报告提供了最新情况,详细介绍了 NHFD 的流程、范围、经验教训并强调了未来的发展方向。
{"title":"The National Hip Fracture Database: lessons learned and future horizons","authors":"Will Eardley,&nbsp;Antony Johansen","doi":"10.1016/j.mporth.2024.01.007","DOIUrl":"https://doi.org/10.1016/j.mporth.2024.01.007","url":null,"abstract":"<div><p>The effective management of older patients with fragility fractures of the femur remains central to modern trauma care. Processes of assessment and communication alongside means of identifying poor performance are vital to improving care in this population. The National Hip Fracture Database (NHFD) now contains around 1 million cases and has evolved over time to reflect contemporary practices in the care of older injured patients. The NHFD is in a unique position to inform hip fracture care and the wider global management of injured older patients. This report provides an update and details the processes within the NHFD, the scope, lessons learned and highlights future direction.</p></div>","PeriodicalId":39547,"journal":{"name":"Orthopaedics and Trauma","volume":"38 2","pages":"Pages 108-113"},"PeriodicalIF":0.0,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140290501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The management of intertrochanteric hip fractures: an update 髋关节转子间骨折的治疗:最新进展
Q4 Medicine Pub Date : 2024-02-20 DOI: 10.1016/j.mporth.2024.01.001
Sophia M. Wakefield, Paul L. Rodham, Peter V. Giannoudis

Intertrochanteric fractures are a common type of proximal femoral fracture, and account for high morbidity and mortality. Early recognition and management of such fractures is important, with surgery preferably undertaken within 48 hours. The choice of surgical strategy remains variable between centres and individual surgeons; in part because evidence to support a specific strategy has been weak. Herein, we provide the latest evidence on the management of these fractures.

股骨转子间骨折是股骨近端骨折的常见类型,发病率和死亡率都很高。早期识别和处理此类骨折非常重要,最好在48小时内进行手术。不同中心和不同外科医生对手术策略的选择仍不尽相同,部分原因是支持特定策略的证据不足。在此,我们将提供有关此类骨折治疗的最新证据。
{"title":"The management of intertrochanteric hip fractures: an update","authors":"Sophia M. Wakefield,&nbsp;Paul L. Rodham,&nbsp;Peter V. Giannoudis","doi":"10.1016/j.mporth.2024.01.001","DOIUrl":"https://doi.org/10.1016/j.mporth.2024.01.001","url":null,"abstract":"<div><p>Intertrochanteric fractures are a common type of proximal femoral fracture, and account for high morbidity and mortality. Early recognition and management of such fractures is important, with surgery preferably undertaken within 48 hours. The choice of surgical strategy remains variable between centres and individual surgeons; in part because evidence to support a specific strategy has been weak. Herein, we provide the latest evidence on the management of these fractures.</p></div>","PeriodicalId":39547,"journal":{"name":"Orthopaedics and Trauma","volume":"38 2","pages":"Pages 70-77"},"PeriodicalIF":0.0,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140290383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Orthopaedics and Trauma
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