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临床试验/NCT06755580
NCT06755580已完成不适用

Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
pelvic ring symmetry

研究概览

简要总结

The aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. The aim of the research is to determine whether minimally invasive surgical techniques can achieve comparable fracture reduction and functional outcome as open surgical approaches. Another aim is to determine whether the minimally invasive surgical procedure leads to shorter patient hospitalization, lower perioperative blood loss, and lower postoperative complications.

详细描述

This retrospective study included 51 patients with vertically unstable sacral fracture operated at our institution with open or minimally invasive spinopelvic fixation over a period of 11 years (2014-2024). The patients were divided into two groups. One group of patients underwent open spinopelvic fixation, the other group underwent minimally invasive spinopelvic fixation. Each patient underwent a CT scan before and after surgery. The degree of fracture dislocation and reduction was measured in three planes at each examination. The degree of reduction was divided into four groups according to residual dislocation. In the perioperative period, blood loss, the length of the surgical procedure from the first incision to the suture of the wounds, and radiation exposure were monitored. Intraoperative blood loss was calculated from the waste in the surgical suction system. Functional outcome was assessed one year after surgery. A standardized questionnaire according to the Majeed score was used to assess functional outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 77 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient with high energy vertically unstable sacral fracture
  • patients operated with open or minimally invasive spinopelvic fixation
  • patients followed up for at least one year

排除标准

  • patients with low-energy osteoporotic fractures of the sacrum
  • patients with insufficiency fractures of the sacrum
  • patients operated on using a method other than spinopelvic fixation
  • patients who were not followed up for at least one year after surgery

结局指标

主要结局

pelvic ring symmetry

时间窗: up to 1 year

position of fracture fragments before and after surgery measured in three planes on CT scan

invasiveness of the surgical procedure

时间窗: in perioperative period

The invasiveness of the surgical procedure was measured based on perioperative blood loss. Perioperative blood loss was calculated from the waste in the surgical suction system (mililiters)

length of the surgical procedure

时间窗: in perioperative period

length of the surgical procedure from the first incision to the suture of the wounds

radiation exposure of the patient during surgical procedure

时间窗: in perioperative period

radiation exposure of a patient during a surgical procedure measured by the X-ray machine used during the operation (microgray/m2)

Functional outcome after surgery based on a standardized questionnaire according to the Majeed score

时间窗: one year after surgery

One year after surgery, patients fill out a standardized questionnaire according to the Majeed scoring system. Majeed score is a pelvic injury-specific functional assessment that comprises seven items, including pain, work, sitting, sexual intercourse, standing, unaided gait, and walking distance, with a total score range of 0 (worst outcome) to100 (best outcome), in order of decreasing disability.

complications

时间窗: 1 year

During the observation period, postoperative complications such as wound infection, loosening of osteosynthetic material, loss of reduction, nonunion, and newly developed neurological deficit will be recorded in patients.

次要结局

未报告次要终点

研究者

发起方
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hrin Tomas, MD

Principal investigator

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

研究点 (1)

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