Orthopedic devices

骨科装置
  • 文章类型: Journal Article
    目的本研究旨在确定先天性马蹄内翻足(CC)儿童使用Dennis-Brown矫形器时家庭面临的主要困难。方法本研究通过GoogleForms对2015年至2018年接受治疗的儿童的看护人进行了访谈,了解他们在矫形器使用方面的困难。结果答案显示,矫形器相关的困难与儿童的性别无关,年龄,或受影响的一面。我们注意到41.7%的受访者表示有些困难,尤其是儿童使用矫形器时的刺激(93.3%)。结论CC复发的主要因素是矫形器使用依从性差。因此,研究导致或增加中断矫形器使用的可能性的因素对于创建促进其使用的策略具有重要意义,可能减少CC复发。
    Objective This study aimed to identify the main difficulties faced by the family when a child with congenital clubfoot (CC) uses the Dennis-Brown orthosis. Method  This study interviewed via Google Forms caregivers of children treated from 2015 to 2018 regarding their difficulties in orthosis use. Results  The answers revealed that orthosis-related difficulties are independent of the child\'s gender, age, or affected side. We noted that 41.7% of the respondents reported some difficulty, especially the child\'s irritation when using the orthosis (93.3%). Conclusion  The main factor in CC relapses is poor adherence to orthosis use. As a result, studying factors causing or increasing the probability of interrupting orthosis use is significant in creating strategies to facilitate their use, potentially reducing CC recurrence.
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  • 文章类型: Journal Article
    评估改良的保留肌肉后入路的效果;SPEIRE(保存梨状肌和内内肌,修复Externus),与标准外侧入路相比,半髋关节置换术治疗移位的囊内骨折对术后活动度和功能的影响。
    务实,优越性,多中心,平行组,随机对照试验(内部试点)。参与者,病房工作人员,进行术后评估的研究人员对分配不知情.CTU使用计算机生成的列表集中分配治疗。
    英格兰西南部的六家医院,招聘2019年11月25日-2022年4月25日。
    244名需要髋关节置换术的成年人(≥60岁)(每种入路分配122名)。分配给SPAIRE和横向的90名和85名参与者,分别,在预设的数据收集窗口内有主要结局数据.
    使用SPAIRE或标准外侧入路进行手术。术后3天和120天随访。
    牛津髋关节评分(OHS),通过电话在120天。次要结果:功能和流动性(3天),疼痛(3天,120天),排放目的地,住院时间,并发症和死亡率(120天内),生活质量和居住地(120天)。
    参与者的平均年龄为84.6岁(SD7.2);168名(69%)为女性。主要结果:120天时OHS差异的证据很少;调整后的平均差异(SPAIRE-侧向)-1.23(95%CI-3.96至1.49,p=0.37)。次要结果:在SPAIRE组3天时,参与者报告的疼痛程度较低;其余结果在两组之间没有差异。
    参与者\'的流动性和功能在短期(3天)和长期(120天)方面相似,无论是接收SPAIRE还是横向进近。在住院时间方面,这两种方法都不能比另一种方法受益。返回骨折前住所,在120天内存活,或120天的生活质量。接受SPAIRE方法的参与者在术后早期可能会经历较少的疼痛。在120天内,将髋关节置换术中的后入路修改为SPAIRE入路可使患者的预后与外侧入路相同。
    NCT04095611。
    UNASSIGNED: Assess the effect of a modified muscle sparing posterior approach; SPAIRE (Save Piriformis and Internus, Repairing Externus), in hip hemiarthroplasty for displaced intracapsular fractures on postoperative mobility and function compared with a standard lateral approach.
    UNASSIGNED: Pragmatic, superiority, multicenter, parallel-group, randomized controlled trial (with internal pilot). Participants, ward staff, and research staff conducting postoperative assessments were blinded to allocation. A CTU allocated treatments centrally using computer-generated lists.
    UNASSIGNED: Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022.
    UNASSIGNED: 244 adults (≥60 years) requiring hip hemiarthroplasty (122 allocated to each approach). 90 and 85 participants allocated to SPAIRE and lateral, respectively, had primary outcome data within the prespecified data collection window.
    UNASSIGNED: Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation.
    UNASSIGNED: Oxford Hip Score (OHS), via telephone at 120 days. Secondary outcomes: function and mobility (3 days), pain (3 days, 120 days), discharge destination, length of hospital stay, complications and mortality (within 120 days), quality of life and place of residence (120 days).
    UNASSIGNED: Participants\' mean age was 84.6 years (SD 7.2); 168 (69%) were women. Primary outcome: little evidence of a difference in OHS at 120 days; adjusted mean difference (SPAIRE-lateral) -1.23 (95% CI -3.96 to 1.49, p=0.37). Secondary outcomes: indication of lower participant-reported pain at 3 days in SPAIRE arm; no differences between arms for remaining outcomes.
    UNASSIGNED: Participants\' mobility and function are similar in the short term (3 days) and longer term (120 days), whether receiving the SPAIRE or lateral approach. Neither approach confers benefit over the other in terms of length of hospital stay, return to prefracture residence, survival within 120 days, or quality of life at 120 days. Participants receiving SPAIRE approach may experience less pain in the early postoperative period. Modifying the posterior approach in hip hemiarthroplasty to the SPAIRE approach gives equivalent patient outcomes to the lateral approach within 120 days.
    UNASSIGNED: NCT04095611.
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  • 文章类型: Journal Article
    人工关节置换是目前应用最广泛的修复大型骨缺损的手术方法,尽管它通常与人工关节感染(PJI)有关,由生物膜形成引起。为了解决PJI问题,已经提出了各种方法,包括用具有抗菌活性的纳米材料涂覆可植入装置。其中,银纳米粒子(AgNPs)是最常用的生物医学应用,尽管它们的使用受到细胞毒性的限制。因此,已经进行了几项研究来评估最合适的AgNPs浓度,尺寸,和形状以避免细胞毒性作用。人们一直非常关注Ag纳米枝晶,由于它们有趣的化学物质,光学,和生物学特性。在这项研究中,我们评估了人胎儿成骨细胞(hFOB)和铜绿假单胞菌和金黄色葡萄球菌在硅基技术(Si_Ag)产生的分形银枝晶基底上的生物学反应。体外结果表明,在Si_Ag表面培养72h的hFOB细胞具有良好的细胞相容性。使用革兰氏阳性(S.金黄色葡萄球菌)和革兰氏阴性(P.铜绿假)细菌菌株在Si_Ag上孵育24小时显示病原体活力显著降低,铜绿假单胞菌比金黄色葡萄球菌更明显。这些发现共同表明,分形银枝晶可以代表可植入医疗设备涂层的合格纳米材料。
    Prosthetic joint replacement is the most widely used surgical approach to repair large bone defects, although it is often associated with prosthetic joint infection (PJI), caused by biofilm formation. To solve the PJI problem, various approaches have been proposed, including the coating of implantable devices with nanomaterials that exhibit antibacterial activity. Among these, silver nanoparticles (AgNPs) are the most used for biomedical applications, even though their use has been limited by their cytotoxicity. Therefore, several studies have been performed to evaluate the most appropriate AgNPs concentration, size, and shape to avoid cytotoxic effects. Great attention has been focused on Ag nanodendrites, due to their interesting chemical, optical, and biological properties. In this study, we evaluated the biological response of human fetal osteoblastic cells (hFOB) and P. aeruginosa and S. aureus bacteria on fractal silver dendrite substrates produced by silicon-based technology (Si_Ag). In vitro results indicated that hFOB cells cultured for 72 h on the Si_Ag surface display a good cytocompatibility. Investigations using both Gram-positive (S. aureus) and Gram-negative (P. aeruginosa) bacterial strains incubated on Si_Ag for 24 h show a significant decrease in pathogen viability, more evident for P. aeruginosa than for S. aureus. These findings taken together suggest that fractal silver dendrite could represent an eligible nanomaterial for the coating of implantable medical devices.
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  • 文章类型: Journal Article
    未经评估:膝关节骨性关节炎是导致身体残疾和生活质量下降的主要原因,终末期疾病通常通过全膝关节置换术(TKR)治疗。我们着手开发和外部验证一种机器学习模型,该模型能够使用常规收集的健康数据在2年和5年内预测TKR的需求。
    UNASSIGNED:使用数据集骨关节炎倡议(OAI)和多中心骨关节炎研究(MOST)的前瞻性研究。OAI数据用于训练模型,而MOST数据形成外部测试集。使用特征选择对数据进行预处理,以策划包括人口统计在内的45个候选特征,病史,成像评估,干预史和结果。
    UNASSIGNED:该研究使用两个基于美国的多中心数据集进行,这些数据集包括患有膝关节OA或处于膝关节OA高风险的参与者。
    UNASSIGNED:该研究排除了至少有一个TKR的参与者。OAI数据集包括45-79岁的参与者,其中3234人用于培训,809人用于内部测试,而MOST涉及50-79岁和2248岁的参与者用于外部测试。
    未经评估:本研究的主要结果是预测2年和5年的TKR发病。使用曲线下面积(AUC)和F1评分以及确定的关键预测因子来评估性能。
    UNASSIGNED:对于性能最佳的模型(梯度提升机),2年时的AUC为0.913(95%CI0.876至0.951),5年时0.873(95%CI0.839至0.907)。射线照相衍生特征,基于问卷的评估以及患者的教育程度是这些模型的关键预测因子。
    UNASSIGNED:我们的方法表明,常规收集的患者数据足以驱动具有临床可接受的准确性水平(AUC>0.7)的预测模型,并且是第一个外部验证的此类工具。这种精度水平高于以前发表的利用MRI数据的模型,这不是常规收集的。
    UNASSIGNED: Knee osteoarthritis is a major cause of physical disability and reduced quality of life, with end-stage disease often treated by total knee replacement (TKR). We set out to develop and externally validate a machine learning model capable of predicting the need for a TKR in 2 and 5 years time using routinely collected health data.
    UNASSIGNED: A prospective study using datasets Osteoarthritis Initiative (OAI) and the Multicentre Osteoarthritis Study (MOST). OAI data were used to train the models while MOST data formed the external test set. The data were preprocessed using feature selection to curate 45 candidate features including demographics, medical history, imaging assessments, history of intervention and outcome.
    UNASSIGNED: The study was conducted using two multicentre USA-based datasets of participants with or at high risk of knee OA.
    UNASSIGNED: The study excluded participants with at least one existing TKR. OAI dataset included participants aged 45-79 years of which 3234 were used for training and 809 for internal testing, while MOST involved participants aged 50-79 and 2248 were used for external testing.
    UNASSIGNED: The primary outcome of this study was prediction of TKR onset at 2 and 5 years. Performance was evaluated using area under the curve (AUC) and F1-score and key predictors identified.
    UNASSIGNED: For the best performing model (gradient boosting machine), the AUC at 2 years was 0.913 (95% CI 0.876 to 0.951), and at 5 years 0.873 (95% CI 0.839 to 0.907). Radiographic-derived features, questionnaire-based assessments alongside the patient\'s educational attainment were key predictors for these models.
    UNASSIGNED: Our approach suggests that routinely collected patient data are sufficient to drive a predictive model with a clinically acceptable level of accuracy (AUC>0.7) and is the first such tool to be externally validated. This level of accuracy is higher than previously published models utilising MRI data, which is not routinely collected.
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  • 文章类型: Journal Article
    Joint stiffness is the most common complication in elbow injuries, presenting several etiologies and pathophysiological mechanisms that hinder treatment and prognosis. Prevention and treatment of joint contracture depend on the cause of stiffness, and early intervention should modify its outcomes. The methods used may be conservative or surgical, alone or in combination, according to each individual situation.
    UNASSIGNED: Review articles on articulated elbow orthosis for joint stiffness rehabilitation.
    UNASSIGNED: A literature review was conducted in journals available at the PubMed, Medline and LILACS databases, using the following Health Science Descriptors (DeCS): orthotic devices; braces; elbow; elbow joint; contracture; joint disorders. It sought to retrieve and analyze studies with the highest level of evidence that have already been conducted on articulated elbow orthosis for joint stiffness rehabilitation.
    UNASSIGNED: After applying the inclusion and exclusion criteria, four articles were included from PubMed and none from Medline or LILACS. Of the four PubMed articles, two were systematic reviews and two were randomized clinical trials.
    UNASSIGNED: Articulated elbow orthoses can benefit joint stiffness treatment, improving range of motion and pain, showing superior effect compared to non-articulated plaster orthotics. Level of Evidence III, Systematic Review of Level III Studies.
    A rigidez articular é a principal complicação do cotovelo, afetando o tratamento e o prognóstico. O manejo da contratura articular se baseia na sua etiologia, e a intervenção precoce deve modificar o desfecho dessa complicação.
    UNASSIGNED: Revisar artigos sobre órtese articulada de cotovelo para reabilitação de rigidez articular.
    UNASSIGNED: Foi realizada uma revisão bibliográfica em periódicos disponíveis do PubMed, Medline e LILACS, utilizando os Descritores em Ciências da Saúde (DeCS): aparelhos ortopédicos; braquetes; cotovelo; articulação do cotovelo; contratura; e transtornos da articulação. A intenção foi estabelecer e conhecer estudos de alto poder de evidência já realizados, que tenham tido como referência a temática de órteses articuladas de cotovelo para reabilitação de rigidez articular.
    UNASSIGNED: Após a aplicação dos critérios de inclusão e exclusão, revisaram-se artigos indexados no PubMed, Medline e LILACS, encontrando-se quatro artigos pelo PubMed e nenhum pelo Medline ou LILACS. Dos quatro artigos, dois eram revisões sistemáticas e dois eram ensaios clínicos randomizados. Conclusão: Órteses articuladas de cotovelo podem ser benéficas no tratamento de rigidez articular, sendo sugerido que melhoram amplitude de movimentos (ADM) e dor, inclusive com efeito superior em relação às órteses não articuladas gessadas. Nível de Evidência III, Revisão Sistemática de Estudos de Nível III.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    食品和药物管理局(FDA)的设备和放射健康中心的使命是保护和促进公众健康。它确保患者和提供者能够及时和持续地获得安全,有效,以及高质量的医疗设备和安全的辐射产品,通过提供有关我们监管的产品和我们做出的决定的有意义和及时的信息。2021年9月17日,举行了FDA研讨会,向利益相关者提供信息,包括脊柱社区的成员,设备制造商,监管事务专业人员,临床医生,病人,和公众对FDA的规定,与脊柱器械临床回顾相关的指导和调节途径。它无意传达任何新政策,进程,或关于医疗器械营销授权的解释。这个研讨会由个人介绍组成,小组讨论,问答环节,和受众调查。信息共享包括与患者报告结果相关的讨论,临床医生报告的结果,观察员报告的结果,和绩效结果。涉及外部主题专家的讨论涵盖了与脊柱器械临床研究相关的主题,包括目标人群的定义,入学标准,纳入代表性不足的患者组的策略,不良事件和二次外科手术的报告,临床研究终点,和临床结果评估。会议记录和网络广播研讨会链接目前已发布在FDA网站上。讨论了重要的相关问题和挑战,并分享了一系列令人兴奋的新想法和概念,这些想法和概念有望推进监管科学,患者护理和与脊柱设备相关的未来创新。
    The mission of Food and Drug Administration (FDA)\'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    目的:本研究旨在确定与初次选择性全膝关节置换术(TKA)后翻修(任何原因)和需要手术的深部感染风险增加相关的年外科医生容量阈值。
    方法:倾向评分匹配队列研究。
    方法:安大略省,加拿大。
    方法:在2002年至2016年期间接受原发性TKA的169713人,术后随访3年。
    方法:修复关节成形术(任何原因),以及需要手术的深部手术感染的发生。
    结果:基于受限三次样条分析,需要手术的翻修和深部感染概率增加的阈值为<70例/年.在将51658名来自执行<70例/年的外科医生的TKA接受者与来自大于70例/年的外科医生的TKA接受者进行匹配后,前一组患者的翻修率较高(无论出于何种原因,2.23%(95%置信区间(CI)1.39至3.07)vs1.70%(95%CI0.85至2.55);危险比(HR)1.33,95%CI1.21至1.47,p<0.0001)和需要手术的深部感染(1.29%(95%CI0.44至2.14)vs1.09%(95%CI0.24至1.94);HR1.33,95%CI1.17,p<1.51
    结论:对于主要的TKA接受者,在指标TKA之前的一年中,执行TKA少于70个TKA的外科医生所执行的病例(由于任何原因)的相对翻修风险增加了31%,需要手术的深部手术感染的相对风险增加了18%,3年随访。
    OBJECTIVE: This study aimed to identify a threshold in annual surgeon volume associated with increased risk of revision (for any cause) and deep infection requiring surgery following primary elective total knee arthroplasty (TKA).
    METHODS: A propensity score matched cohort study.
    METHODS: Ontario, Canada.
    METHODS: 169 713 persons who received a primary TKA between 2002 and 2016, with 3-year postoperative follow-up.
    METHODS: Revision arthroplasty (for any cause), and the occurrence of deep surgical infection requiring surgery.
    RESULTS: Based on restricted cubic spline analysis, the threshold for increased probability of revision and deep infection requiring surgery was <70 cases/year. After matching of 51 658 TKA recipients from surgeons performing <70 cases/year to TKA recipients from surgeons with greater than 70 cases/year, patients in the former group had a higher rate of revision (for any cause, 2.23% (95% Confidence Interval (CI) 1.39 to 3.07) vs 1.70% (95% CI 0.85 to 2.55); Hazard Ratio (HR) 1.33, 95% CI 1.21 to 1.47, p<0.0001) and deep infection requiring surgery (1.29% (95% CI 0.44 to 2.14) vs 1.09% (95% CI 0.24 to 1.94); HR 1.33, 95% CI 1.17 to 1.51, p<0.0001).
    CONCLUSIONS: For primary TKA recipients, cases performed by surgeons who had performed fewer than 70 TKAs in the year prior to the index TKA were at 31% increased relative risk of revision (for any cause), and 18% increased relative risk for deep surgical infection requiring surgery, at 3-year follow-up.
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  • 文章类型: Journal Article
    大约三分之二的踝关节骨折是单踝关节损伤,韦伯B型腓骨骨折是迄今为止最常见的类型。根据创伤和随之而来的软组织损伤,这些骨折要么稳定,要么不稳定。目前的临床实践指南推荐不稳定韦伯B型腓骨骨折的手术治疗。正在进行的随机调查,平行组,非劣效性试验比较手术和非手术治疗不稳定WeberB型踝关节骨折的分配比例为1:1。非劣效性设计的基本原理如下:通过能够证明非手术治疗的非劣效性,我们就能避免手术相关的并发症.然而,与非手术治疗相关的主要问题是踝关节不一致的风险增加,导致二次手术,早期创伤后骨关节炎和功能差。在提供知情同意后,126名年龄在16岁或以上的单踝韦伯B型不稳定腓骨骨折患者被随机分配到手术(切开复位和内固定)或非手术治疗(6周固定)。我们已经完成了患者登记,目前处于2年随访的最后阶段。主要的,非劣效性结局是2年(主要时间点)的Olerud-Molander踝关节评分(OMAS).预定义的非劣效性裕度设置在8个OMAS点。次要结果包括足踝评分,功能和疼痛的100毫米视觉模拟评分,与健康相关的生活质量的RAND-36项目健康调查,受伤脚踝的活动范围,不愈合(踝关节不协调)和骨折愈合。治疗相关的并发症和危害;有症状的不愈合,失去了踝关节的一致性,再次手术和伤口感染也将被记录。我们假设非手术治疗产生的功能结果不低于手术,目前的标准治疗,没有增加危害的风险。
    Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.
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