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

单层与双层耻骨联合钢板固定治疗C1-2和C1-3骨盆环损伤的随机对照试验

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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}.

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