单联合钢板与双联合钢板治疗C1-2和C1-3骨盆环损伤:一项随机对照试验

IF 1.6 3区 医学 Q2 SURGERY
Islam Sayed Moussa, Ibrahim Mahmoud Abdelmonem, Amr Mohammed Nagy
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引用次数: 0

摘要

背景:单一上联合钢板是治疗垂直不稳定Tile C1-2和C1-3骨盆环损伤最有效的方法。然而,高失败率的植入物在肥胖患者中更为常见(体重指数)方法:该研究被设计为一项前瞻性、随机对照试验,采用单盲方法,在一级创伤中心进行。该研究涉及36名在2022年2月至2023年5月期间患有C1-2和C1-3级损伤和I级肥胖的患者。所有病例均行前后环固定,其中18例上联合钢板,18例前联合钢板(A、B组)。主要结局是放射学、功能结局和种植体失败率。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组的手术时间明显缩短,平均差异为30分钟(p)。结论:作者发现,在I级肥胖患者中,在垂直不稳定的Tile C1-2和C1-3骨盆环损伤中,使用单个高质量的联合钢板可以有效地解决联合移位。该方法通过减少手术次数和减少再手术率来降低发病率,而附加前钢板并不能提高最终的放射学和临床结果。证据水平:治疗性I级研究。试验注册:艾因沙姆斯大学伦理委员会回顾性注册并批准了该试验(FWA 000017585 FMASU R65/2022)。它是根据国际麻醉学统一理事会(ICH)和伊斯兰医学科学组织(IOMS)的准则组织和运作的。美国人类研究保护办公室和美国联邦条例法典根据第000017585号联邦保证(追溯登记)运作。我们的研究已在ClinicalTrials.gov注册,临床试验号NCT06439108,临床试验注册号({05/30/2024})。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Single versus double symphyseal plating in management of tile C1-2 and C1-3 pelvic ring injuries: a randomized controlled trial.

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}.

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来源期刊
BMC Surgery
BMC Surgery SURGERY-
CiteScore
2.90
自引率
5.30%
发文量
391
审稿时长
58 days
期刊介绍: BMC Surgery is an open access, peer-reviewed journal that considers articles on surgical research, training, and practice.
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