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单钢板与双钢板固定治疗Tile C1-2和C1-3型骨盆环损伤的随机对照试验

Single versus double symphyseal plating in management of tile C1-2 and C1-3 pelvic ring injuries: a randomized controlled trial.

作者信息

Moussa Islam Sayed, Abdelmonem Ibrahim Mahmoud, Nagy Amr Mohammed

机构信息

Department of Orthopedics and Traumatology, Faculty of Medicine, Ain Shams University, 56 Ramses Street, Abbasia, Cairo, 11522, Egypt.

出版信息

BMC Surg. 2025 May 9;25(1):200. doi: 10.1186/s12893-025-02936-3.

DOI:10.1186/s12893-025-02936-3
PMID:40346505
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12063314/
Abstract

BACKGROUND

Single superior symphyseal plating is the most effective method for managing vertically unstable Tile C1-2 and C1-3 pelvic ring injuries. However, high rates of implant failure were more frequently observed in obese patients (body mass index < 30). The study aimed to determine the potential reduction in implant failure rates by adding an anterior symphyseal plate in obese patients (class I).

METHODS

The study was designed as a prospective, randomized controlled trial with a single-blind methodology, conducted at a level 1 trauma center. The study involved 36 patients with Tile C1-2 and C1-3 injuries, and class I obesity between February 2022 and May 2023. All cases had posterior and anterior ring fixation, with 18 cases having superior symphyseal plating and 18 cases having additional anterior plating (Groups A and B). The primary outcomes were radiological, functional outcomes, and implant failure rates.

RESULTS

Patients in group A were followed up for an average of 13.39 months, and those in group B for 13.7 months. Group A exhibited a significantly shorter operative time with a mean difference of 30 min (p < 0.001), as well as lower reoperation rates (p = 0.03). Both groups had similar final clinical and radiological outcomes (p = 0.44 and 0.78) and implant failure rates (p = 0.18) at the last follow-up.

CONCLUSION

The authors found that using a single high-quality symphyseal plate effectively addresses symphyseal diastasis in vertically unstable Tile C1-2 and C1-3 pelvic ring injuries among patients with class I obesity. This method lowers morbidity by reducing operation times and minimizing reoperation rates, while the inclusion of an additional anterior plate does not enhance the final radiological and clinical outcomes.

LEVEL OF EVIDENCE

Therapeutic Level I study.

TRIAL REGISTRATION

Ain Shams University's ethical committee retrospectively registered and approved this trial (FWA 000017585 FMASU R65/2022). It was organized and operated according to the guidelines of the International Council on Harmonization (ICH) in Anesthesiology and the Islamic Organization for Medical Sciences (IOMS). The United States Office for Human Research Protections and the United States Code of Federal Regulations operate under Federal Wide Assurance No. 000017585 (retrospectively registered). Our study was registered at ClinicalTrials.gov with clinical trial number NCT06439108 with clinical trial registry ({05/30/2024}.

摘要

背景

单块耻骨联合上缘钢板固定是治疗Tile C1-2和C1-3型垂直不稳定骨盆环损伤最有效的方法。然而,肥胖患者(体重指数<30)的植入物失败率较高。本研究旨在确定在肥胖患者(I类)中增加一块耻骨联合前钢板是否能潜在降低植入物失败率。

方法

本研究设计为一项前瞻性、随机对照试验,采用单盲方法,在一级创伤中心进行。研究纳入了2022年2月至2023年5月期间36例Tile C1-2和C1-3损伤且为I类肥胖的患者。所有病例均进行了前后环固定,其中18例采用耻骨联合上缘钢板固定,18例采用额外的耻骨联合前钢板固定(A组和B组)。主要结局指标为影像学、功能结局和植入物失败率。

结果

A组患者平均随访13.39个月,B组患者平均随访13.7个月。A组手术时间明显更短,平均差异为30分钟(p<0.001),再手术率也更低(p=0.03)。在最后一次随访时,两组的最终临床和影像学结局(p=0.44和0.78)以及植入物失败率(p=0.18)相似。

结论

作者发现,对于I类肥胖患者的Tile C1-2和C1-3型垂直不稳定骨盆环损伤,使用单块高质量耻骨联合钢板可有效解决耻骨联合分离问题。该方法通过缩短手术时间和降低再手术率降低了发病率,而额外增加一块耻骨联合前钢板并未改善最终的影像学和临床结局。

证据水平

治疗性I级研究。

试验注册

艾因夏姆斯大学伦理委员会对本试验进行了回顾性注册和批准(FWA 000017585 FMASU R65/2022)。该研究按照国际人用药品注册技术协调会(ICH)麻醉学指南和伊斯兰医学科学组织(IOMS)的指南进行组织和操作。美国人类研究保护办公室和美国联邦法规法典依据联邦范围保证号000017585(回顾性注册)开展工作。我们的研究在ClinicalTrials.gov上注册,临床试验编号为NCT06439108,临床试验注册日期为{2024年5月30日}。

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