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Orthopaedic infections: what have we learned? 骨科感染:我们学到了什么?
Pub Date : 2023-05-04 eCollection Date: 2023-05-01 DOI: 10.1097/OI9.0000000000000250
Christopher Lee, Erik Mayer, Nicholas Bernthal, Joseph Wenke, Robert V O'Toole

Orthopaedic infections remain challenging complications to treat, with profound economic impact in addition to patient morbidity. The overall estimates of infection after orthopaedic surgery with internal devices has been estimated at 5%, with hospital costs eight times that of those without fracture-related infections and with significantly poorer functional and pain interference PROMIS scores. Orthopaedic infection interventions have been focused on prevention and treatment options. The creation of new modalities for orthopaedic infection treatment can benefit from the understanding of the temporal relationship between bacterial colonization and host-cell integration, a concept referred to as "the race for the surface." Regarding prevention, host modulation and antibiotic powder use have been explored as viable options to lower infection rates. Orthopaedic infection treatment has additionally continued to evolve, with PO antibiotics demonstrating equivalent efficacy to IV antibiotics for the treatment of orthopaedic infections in recent studies. In conclusion, orthopaedic infections remain difficult clinical dilemmas, although evolving prevention and treatment modalities continue to emerge.

骨科感染仍然是治疗难度很大的并发症,除了会导致患者发病外,还会对经济产生深远影响。据估计,使用内部装置进行骨科手术后感染的总体发生率为 5%,住院费用是没有发生骨折相关感染的患者的八倍,而且患者的功能和疼痛干扰 PROMIS 评分明显较低。骨科感染干预措施主要集中在预防和治疗方案上。了解细菌定植与宿主细胞整合之间的时间关系(这一概念被称为 "表面竞赛")将有助于创造骨科感染治疗的新模式。在预防方面,宿主调节和抗生素粉的使用已被视为降低感染率的可行方案。此外,骨科感染治疗也在不断发展,在最近的研究中,口服抗生素与静脉注射抗生素治疗骨科感染的疗效相当。总之,尽管不断出现新的预防和治疗方法,骨科感染仍然是临床上的难题。
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引用次数: 0
Great debates in trauma biomechanics. 创伤生物力学的大辩论。
Pub Date : 2023-05-04 eCollection Date: 2023-05-01 DOI: 10.1097/OI9.0000000000000249
Vaida Glatt, Robert O'Toole, Samir Mehta, William Ricci, Aaron Nauth, Emil Schemitsch, Michael W Hast

At the 2021 annual meeting of the Orthopaedic Trauma Association, the Basic Science Focus Forum hosted its first ever debate-style symposium focused on biomechanics and fracture repair. The 3 subjects of debate were "Mechanics versus Biology-Which is 'More Important' to Consider?" "Locked Plate versus Forward Dynamization versus Reverse Dynamization-Which Way Should I Go?" and "Sawbones versus Cadaver Models-What Should I Believe Most?" These debates were held because fracture healing is a highly organized synergistic response between biological factors and the local mechanical environment. Multiple studies have demonstrated that both factors play roles in governing bone healing responses, and the causal relationships between the 2 remain unclear. The lack of clarity in this space has led to a spectrum of research with the common goal of helping surgeons make good decisions. Before reading further, the reader should understand that the questions posed in the debate titles are unanswerable and might represent a false choice. Instead, the reader should appreciate that the debates were held to gain a more thorough understanding of these topics based on the current state of the art of experimental and clinical studies, by using an engaging and thought-provoking format.

在骨科创伤协会2021年年会上,基础科学焦点论坛举办了有史以来第一次辩论式研讨会,重点讨论生物力学和骨折修复。辩论的三个主题分别是“力学与生物学哪个‘更重要’需要考虑?”“锁定钢板与正向动力化与反向动力化我应该走哪条路?”和“锯骨与尸体模型我最应该相信什么?”之所以举行这些辩论,是因为骨折愈合是生物因素和局部机械因素之间高度组织化的协同反应环境多项研究表明,这两个因素都在控制骨愈合反应中发挥作用,两者之间的因果关系尚不清楚。这一领域的不明确导致了一系列的研究,其共同目标是帮助外科医生做出正确的决定。在进一步阅读之前,读者应该明白,辩论标题中提出的问题是无法回答的,可能代表错误的选择。相反,读者应该意识到,举行辩论是为了在实验和临床研究的现状基础上,通过使用引人入胜和发人深省的形式,对这些主题有更彻底的理解。
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引用次数: 2
Posttraumatic osteoarthritis: from basic science to clinical implications. 创伤后骨关节炎:从基础科学到临床意义。
Pub Date : 2023-05-04 eCollection Date: 2023-05-01 DOI: 10.1097/OI9.0000000000000232
Justin M Haller, Marjolein C H van der Meulen, Steven Olson, Donald Anderson, J Lawrence Marsh, Zachary Working

Posttraumatic osteoarthritis (PTOA) is a subset of osteoarthritis that occurs after joint injury and is associated with degradation of articular cartilage and subchondral bone. As compared with primary osteoarthritis, PTOA occurs in a time window initiated by a traumatic event resulting in damage to layers of joint structure and alterations in joint shape. As techniques in open reduction and internal fixation continue to mature, our success in preventing posttraumatic osteoarthritis has not kept pace. Advances in research in the subchondral bone, inflammatory response, and joint mechanics continue to open our understanding of this posttraumatic process. In addition, there are possibilities emerging as biological agents to therapeutically alter the progression of PTOA.

创伤后骨性关节炎(pta)是骨性关节炎的一个亚型,发生在关节损伤后,与关节软骨和软骨下骨退化有关。与原发性骨关节炎相比,pta发生在创伤性事件引发的时间窗口内,导致关节结构层损伤和关节形状改变。随着切开复位和内固定技术的不断成熟,我们在预防创伤后骨关节炎方面的成功并没有跟上。在软骨下骨、炎症反应和关节力学方面的研究进展继续打开我们对创伤后过程的理解。此外,有可能出现的生物制剂,以治疗性地改变进展的PTOA。
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引用次数: 0
Fracture healing-orthobiologics: from basic science to clinical application. 骨折愈合-骨科:从基础科学到临床应用。
Pub Date : 2023-05-01 DOI: 10.1097/OI9.0000000000000262
Joey P Johnson, Jaimo Ahn, Douglas R Dirschl, John J Wixted, Andrew R Evans

Orthopaedics as a field and a profession is fundamentally concerned with the treatment of musculoskeletal disease, in all of its many forms. Our collective understanding of the cellular mechanisms underlying musculoskeletal pathology resulting from injury continues to evolve, opening novel opportunities to develop orthobiologic treatments to improve care. It is a long path to move from an understanding of cellular pathology to development of successful clinical treatment, and this article proposes to discuss some of the challenges to achieving translational therapies in orthopaedics. The article will focus on challenges that clinicians will likely face in seeking to bring promising treatments forward to clinical practice and strategies for improving success in translational efforts.

骨科作为一个领域和专业,从根本上讲是与各种形式的肌肉骨骼疾病的治疗有关。我们对损伤引起的肌肉骨骼病理的细胞机制的集体理解不断发展,为发展骨科治疗以改善护理提供了新的机会。从对细胞病理学的理解到成功临床治疗的发展,这是一条漫长的道路,本文建议讨论在骨科中实现转化治疗的一些挑战。本文将重点关注临床医生在寻求将有希望的治疗方法引入临床实践时可能面临的挑战,以及提高转化工作成功的策略。
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引用次数: 0
Comparing the volume of vascular intersection of two femoral neck fracture fixation implants using an In silico technique. 用硅技术比较两种股骨颈骨折固定物的血管相交体积。
Pub Date : 2023-05-01 DOI: 10.1097/OI9.0000000000000256
Matthew D Putnam, Andrew Rau, Michael Frohbergh, Kevin Ong, Michael Bushelow, Michael Blauth

Femoral neck fracture displacement with subsequent vascular disruption is one of the factors that contribute to trauma-induced avascular necrosis of the femoral head. Iatrogenic damage of the intraosseous arterial system during fixation of femoral neck fracture is another possible cause of avascular necrosis that is less well understood. Recently, Zhao et al (2017) reconstructed 3D structures of intraosseous blood supply and identified the epiphyseal and inferior retinacular arterial system to be important structures for maintaining the femoral head blood supply after femoral neck fracture. The authors therefore recommended placing implants centrally to reduce iatrogenic vascular injuries. Our in vitro study compared the spatial footprint of a traditional dynamic hip screw with an antirotation screw versus a newly developed hip screw with an integrated antirotation screw on intraosseous vasculature.

Methods: Three dimensional (3D) µCT angiograms of 9 cadaveric proximal femora were produced. Three segmented volumes-porous or cancellous bone, filled or cortical bone, and intraosseous vasculature-were converted to surface files. 3D in silico models of the fixation systems were sized and implanted in silico without visibility of the vascular maps. The volume of vasculature that overlapped with the devices was determined. The ratio of the vascular intersection to the comparator device was calculated, and the mean ratio was determined. A paired design, noninferiority test was used to compare the devices.

Results: Results indicate both significant (P < 0.001) superiority and noninferiority of the hip screw with an integrated antirotation screw when compared with a dynamic hip screw and antirotation screw for the volume of vasculature that overlapped with each device in the femoral neck.

Conclusions: Combining established methods of vascular visualization with newer methods enables an implant's impact on vascular intersection to be assessed in silico. This methodology suggests that when used for femoral neck fracture management, the new device intersects fewer blood vessels than the comparator. Comparative clinical studies are needed to investigate whether these findings correlate with the incidence of avascular necrosis and clinical outcomes.

股骨颈骨折移位和随后的血管破裂是导致创伤性股骨头缺血性坏死的因素之一。股骨颈骨折固定期间骨内动脉系统的医源性损伤是另一种可能的缺血性坏死原因,但目前尚不清楚。近期,Zhao等(2017)重建了骨内血供的三维结构,发现骨骺和下支持带动脉系统是股骨颈骨折后维持股骨头血供的重要结构。因此,作者建议将植入物放置在中心位置以减少医源性血管损伤。我们的体外研究比较了传统的动态防旋转髋关节螺钉与新开发的集成防旋转髋关节螺钉对骨内血管系统的空间影响。方法:对9具尸体股骨近端进行三维(3D)µCT血管造影。三个分节的体积-多孔或松质骨,填充或皮质骨,以及骨内血管-被转换为表面锉。固定系统的三维计算机模型被定形并植入计算机,不可见血管图。确定了与装置重叠的血管体积。计算血管交点与比较器装置的比值,并确定其平均比值。采用配对设计、非劣效性检验对设备进行比较。结果:结果显示,与动态髋关节螺钉和防旋转螺钉相比,集成防旋转螺钉在股骨颈重叠的血管体积方面具有显著的优势和非劣势(P < 0.001)。结论:将现有的血管可视化方法与较新的方法相结合,可以在计算机上评估植入物对血管相交的影响。该方法表明,当用于股骨颈骨折治疗时,新装置比比较器相交的血管更少。需要比较临床研究来调查这些发现是否与无血管坏死的发生率和临床结果相关。
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引用次数: 0
Reaming the intramedullary canal during tibial nailing does not affect in vivo intramuscular pH of the anterior tibialis. 胫骨钉入时扩髓管不影响胫骨前肌内pH值。
Pub Date : 2023-05-01 DOI: 10.1097/OI9.0000000000000248
Loren O Black, Megan Rushkin, Karalynn Lancaster, J Samuel Cheesman, James E Meeker, Jung U Yoo, Darin M Friess, Zachary M Working

Many investigations have evaluated local and systemic consequences of intramedullary (IM) reaming and suggest that reaming may cause, or exacerbate, injury to the soft tissues adjacent to fractures. To date, no study has examined the effect on local muscular physiology as measured by intramuscular pH (IpH). Here, we observe in vivo IpH during IM reaming for tibia fractures.

Methods: Adults with acute tibia shaft fractures (level 1, academic, 2019-2021) were offered enrollment in an observational cohort. During IM nailing, a sterile, validated IpH probe was placed into the anterior tibialis (<5 cm from fracture, continuous sampling, independent research team). IpH before, during, and after reaming was averaged and compared through repeated measures ANOVA. As the appropriate period to analyze IpH during reaming is unknown, the analysis was repeated over periods of 0.5, 1, 2, 5, 10, and 15 minutes prereaming and postreaming time intervals.

Results: Sixteen subjects with tibia shaft fractures were observed during nailing. Average time from injury to surgery was 35.0 hours (SD, 31.8). Starting and ending perioperative IpH was acidic, averaging 6.64 (SD, 0.21) and 6.74 (SD, 0.17), respectively. Average reaming time lasted 15 minutes. Average IpH during reaming was 6.73 (SD, 0.15). There was no difference in IpH between prereaming, intrareaming, and postreaming periods. IpH did not differ regardless of analysis over short or long time domains compared with the duration of reaming.

Conclusions: Reaming does not affect IpH. Both granular and broad time domains were tested, revealing no observable local impact.

许多研究已经评估了髓内扩孔的局部和全身后果,并表明扩孔可能导致或加剧骨折附近软组织的损伤。到目前为止,还没有研究通过肌内pH值(IpH)检测对局部肌肉生理的影响。在这里,我们观察了胫骨骨折IM扩孔过程中的体内IpH。方法:对急性胫骨干骨折的成人(1级,学术,2019-2021)进行观察性队列研究。在内钉过程中,将一根无菌的、经过验证的IpH探针置入胫骨前肌(结果:在内钉过程中观察了16例胫骨干骨折患者。从损伤到手术的平均时间为35.0小时(SD, 31.8)。围手术期开始和结束IpH为酸性,平均分别为6.64 (SD, 0.21)和6.74 (SD, 0.17)。平均扩眼时间为15分钟。扩孔期间的平均IpH为6.73 (SD, 0.15)。在预学习、内学习和后学习期间,IpH没有差异。与扩孔持续时间相比,无论对短时间域还是长时间域进行分析,IpH都没有差异。结论:扩孔对IpH无影响。颗粒和广泛的时间域都进行了测试,没有发现可观察到的局部影响。
{"title":"Reaming the intramedullary canal during tibial nailing does not affect in vivo intramuscular pH of the anterior tibialis.","authors":"Loren O Black,&nbsp;Megan Rushkin,&nbsp;Karalynn Lancaster,&nbsp;J Samuel Cheesman,&nbsp;James E Meeker,&nbsp;Jung U Yoo,&nbsp;Darin M Friess,&nbsp;Zachary M Working","doi":"10.1097/OI9.0000000000000248","DOIUrl":"https://doi.org/10.1097/OI9.0000000000000248","url":null,"abstract":"<p><p>Many investigations have evaluated local and systemic consequences of intramedullary (IM) reaming and suggest that reaming may cause, or exacerbate, injury to the soft tissues adjacent to fractures. To date, no study has examined the effect on local muscular physiology as measured by intramuscular pH (IpH). Here, we observe in vivo IpH during IM reaming for tibia fractures.</p><p><strong>Methods: </strong>Adults with acute tibia shaft fractures (level 1, academic, 2019-2021) were offered enrollment in an observational cohort. During IM nailing, a sterile, validated IpH probe was placed into the anterior tibialis (<5 cm from fracture, continuous sampling, independent research team). IpH before, during, and after reaming was averaged and compared through repeated measures ANOVA. As the appropriate period to analyze IpH during reaming is unknown, the analysis was repeated over periods of 0.5, 1, 2, 5, 10, and 15 minutes prereaming and postreaming time intervals.</p><p><strong>Results: </strong>Sixteen subjects with tibia shaft fractures were observed during nailing. Average time from injury to surgery was 35.0 hours (SD, 31.8). Starting and ending perioperative IpH was acidic, averaging 6.64 (SD, 0.21) and 6.74 (SD, 0.17), respectively. Average reaming time lasted 15 minutes. Average IpH during reaming was 6.73 (SD, 0.15). There was no difference in IpH between prereaming, intrareaming, and postreaming periods. IpH did not differ regardless of analysis over short or long time domains compared with the duration of reaming.</p><p><strong>Conclusions: </strong>Reaming does not affect IpH. Both granular and broad time domains were tested, revealing no observable local impact.</p>","PeriodicalId":74381,"journal":{"name":"OTA international : the open access journal of orthopaedic trauma","volume":"6 2 Suppl","pages":"e248"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f4/65/oi9-6-e248.PMC10166333.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9446069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Simple design and analysis strategies for solving problems in observational orthopaedic clinical research. 骨科观察性临床研究中解决问题的简单设计与分析策略。
Pub Date : 2023-05-01 DOI: 10.1097/OI9.0000000000000239
Kelsey E Brown, Michael J Flores, Gerard Slobogean, David Shearer, Ida Leah Gitajn, Saam Morshed

Randomized controlled trials are the gold standard to establishing causal relationships in clinical research. However, these studies are expensive and time consuming to conduct. This article aims to provide orthopaedic surgeons and clinical researchers with methodology to optimize inference and minimize bias in observational studies that are often much more feasible to undertake. To mitigate the risk of bias arising from their nonexperimental design, researchers must first understand the ways in which measured covariates can influence treatment, outcomes, and missingness of follow-up data. With knowledge of these relationships, researchers can then build causal diagrams to best understand how to control sources of bias. Some common techniques for controlling for bias include matching, regression, stratification, and propensity score analysis. Selection bias may result from loss to follow-up and missing data. Strategies such as multiple imputation and time-to-event analysis can be useful for handling missingness. For longitudinal data, repeated measures allow observational studies to best summarize the impact of the intervention over time. Clinical researchers familiar with fundamental concepts of causal inference and techniques reviewed in this article will have the power to improve the quality of inferences made from clinical research in orthopaedic trauma surgery.

随机对照试验是临床研究中建立因果关系的黄金标准。然而,这些研究既昂贵又耗时。本文旨在为骨科医生和临床研究人员提供在观察性研究中优化推理和最小化偏差的方法,这些研究通常更可行。为了减轻非实验设计引起的偏倚风险,研究人员必须首先了解测量协变量影响治疗、结果和随访数据缺失的方式。有了这些关系的知识,研究人员就可以建立因果关系图,以最好地了解如何控制偏见的来源。控制偏差的一些常用技术包括匹配、回归、分层和倾向评分分析。选择偏差可能是由于缺少随访和数据缺失造成的。诸如多重输入和事件时间分析等策略对于处理缺失非常有用。对于纵向数据,重复测量使观察性研究能够最好地总结干预措施随时间的影响。熟悉因果推理的基本概念和本文所述技术的临床研究人员将有能力提高从骨科创伤外科临床研究中得出的推论的质量。
{"title":"Simple design and analysis strategies for solving problems in observational orthopaedic clinical research.","authors":"Kelsey E Brown,&nbsp;Michael J Flores,&nbsp;Gerard Slobogean,&nbsp;David Shearer,&nbsp;Ida Leah Gitajn,&nbsp;Saam Morshed","doi":"10.1097/OI9.0000000000000239","DOIUrl":"https://doi.org/10.1097/OI9.0000000000000239","url":null,"abstract":"<p><p>Randomized controlled trials are the gold standard to establishing causal relationships in clinical research. However, these studies are expensive and time consuming to conduct. This article aims to provide orthopaedic surgeons and clinical researchers with methodology to optimize inference and minimize bias in observational studies that are often much more feasible to undertake. To mitigate the risk of bias arising from their nonexperimental design, researchers must first understand the ways in which measured covariates can influence treatment, outcomes, and missingness of follow-up data. With knowledge of these relationships, researchers can then build causal diagrams to best understand how to control sources of bias. Some common techniques for controlling for bias include matching, regression, stratification, and propensity score analysis. Selection bias may result from loss to follow-up and missing data. Strategies such as multiple imputation and time-to-event analysis can be useful for handling missingness. For longitudinal data, repeated measures allow observational studies to best summarize the impact of the intervention over time. Clinical researchers familiar with fundamental concepts of causal inference and techniques reviewed in this article will have the power to improve the quality of inferences made from clinical research in orthopaedic trauma surgery.</p>","PeriodicalId":74381,"journal":{"name":"OTA international : the open access journal of orthopaedic trauma","volume":"6 2 Suppl","pages":"e239"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/86/a0/oi9-6-e239.PMC10166364.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9446067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Basic Science Focus Forum supplement of the Orthopaedic Trauma Association 2022 2022年骨科创伤协会基础科学焦点论坛增刊
Pub Date : 2023-05-01 DOI: 10.1097/OI9.0000000000000243
A. Nauth
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引用次数: 0
Managing periprosthetic fractures: perspectives on periprosthetic pelvic fractures. 假体周围骨折的处理:骨盆假体周围骨折的观点。
Pub Date : 2023-03-28 eCollection Date: 2023-03-01 DOI: 10.1097/OI9.0000000000000266
Victor A de Ridder, Hans-Christoph Pape, Francisco Chana-Rodríguez, Mehdi Boudissa, Claudio Glowalla, Fabian Stuby, Steven Herath, Tina Histing, Konstantinos Tilkeridis, Zoe Dailiana

Periacetabular periprosthetic fractures are rare but potentially disastrous for the longevity of the adjacent implants, leading to multiple revision surgeries. It is of paramount importance to identify and treat intraoperative fractures, which will lead to satisfactory results. Postoperative fractures may be managed operatively or nonoperatively depending on the patient's pain and function, the fracture pattern, and the stability of the acetabular component.

髋臼周围假体周围骨折是罕见的,但对相邻假体的寿命可能是灾难性的,导致多次翻修手术。术中骨折的识别和治疗是至关重要的,这将导致令人满意的结果。术后骨折可采用手术或非手术治疗,这取决于患者的疼痛和功能、骨折类型和髋臼部件的稳定性。
{"title":"Managing periprosthetic fractures: perspectives on periprosthetic pelvic fractures.","authors":"Victor A de Ridder, Hans-Christoph Pape, Francisco Chana-Rodríguez, Mehdi Boudissa, Claudio Glowalla, Fabian Stuby, Steven Herath, Tina Histing, Konstantinos Tilkeridis, Zoe Dailiana","doi":"10.1097/OI9.0000000000000266","DOIUrl":"10.1097/OI9.0000000000000266","url":null,"abstract":"<p><p>Periacetabular periprosthetic fractures are rare but potentially disastrous for the longevity of the adjacent implants, leading to multiple revision surgeries. It is of paramount importance to identify and treat intraoperative fractures, which will lead to satisfactory results. Postoperative fractures may be managed operatively or nonoperatively depending on the patient's pain and function, the fracture pattern, and the stability of the acetabular component.</p>","PeriodicalId":74381,"journal":{"name":"OTA international : the open access journal of orthopaedic trauma","volume":"6 1 Suppl","pages":"e266"},"PeriodicalIF":0.0,"publicationDate":"2023-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d7/bc/oi9-6-e266.PMC10064643.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9233849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia). 一项蒙面随机对照试验,评估开放性胫骨骨折中局部庆大霉素与生理盐水的对比(pGO-胫骨)。
Pub Date : 2023-03-27 eCollection Date: 2023-06-01 DOI: 10.1097/OI9.0000000000000268
Billy T Haonga, Patrick Ngunyale, Ericka P von Kaeppler, Claire A Donnelley, Nae Y Won, Edmund N Eliezer, Kelsey Brown, Michael Flores, Jamieson M O'Marr, Patricia Rodarte, Mayur Urva, Abigail Cortez, Travis Porco, Saam Morshed, David W Shearer

Background: Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture.

Methods: This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection.

Results: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Complete data were recorded at baseline and follow-up for >95% of cases. The rate of follow-up at 6 weeks, 3 months, 6 months, 9 months, and 1 year were 70%, 68%, 69%, 61%, and 80%, respectively. There was no difference in adverse events or any of the measured primary and secondary outcomes.

Conclusion: This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrollment and follow-up to address this topic is possible in this setting.

背景:胫骨开放性骨折的感染风险很高,可导致严重的发病率。在开放性伤口局部使用抗生素是一种潜在有效的预防措施,但评估氨基糖苷类抗生素的数据有限。本研究的目的是评估临床试验的可行性,以测试局部使用庆大霉素对降低开放性胫骨骨折后骨折相关感染风险的疗效:本研究是在穆汉比利骨科研究所进行的一项单中心、试验性、蒙面随机对照试验。参与者在术中伤口闭合后随机接受庆大霉素溶液或生理盐水溶液注射。随访时间分别为术后 2 周、6 周、3 个月、6 个月、9 个月和 1 年。主要的可行性结果是入选率和保留率。主要临床结果是骨折相关感染的发生率:结果:在筛选出的 199 名患者中,有 100 名符合条件的患者在 9 个月内成功入组并接受随机治疗(11.1 人/月)。95%以上的病例在基线和随访时记录了完整的数据。6周、3个月、6个月、9个月和1年的随访率分别为70%、68%、69%、61%和80%。不良事件或任何主要和次要测量结果均无差异:这项试点研究是首批对开放性胫骨骨折局部注射庆大霉素进行评估的研究之一。研究结果表明,在这种情况下,可以通过严格的临床试验,以可接受的入组率和随访率来解决这一问题。
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引用次数: 0
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OTA international : the open access journal of orthopaedic trauma
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