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临床试验/NCT07115602
NCT07115602已完成不适用

Retrospective Multi-expert Diagnostic Imaging Evaluation of Pelvic Ring Injuries: Methodology for Transferring Large DICOM Data Volumes to Remote Experts, and Survey Designed to Isolate Information Obtained From Different Imaging Modalities

Axel Gamulin0 个研究点目标入组 28 人开始时间: 2012年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
主要终点
Arbeitsgemeinschaft für Osteosynthesefragen / Orthopaedic Trauma Association (AO/OTA) classification

研究概览

简要总结

The aim of this retrospective cohort study based on a prospectively filled registry was to determine whether standard anteroposterior pelvic radiographs with and without pelvic binder provide valuable information on pelvic ring injury anatomy and stability when compared to computed tomography images alone. The ultimate goal was to improve the management of these injuries in both emergency and definitive treatment.

详细描述

At the core of the study was a stepwise pelvic imaging evaluation of pelvic ring injury patients by a panel of international pelvic trauma experts. The assessment was conducted in 3 sequential steps:

  1. Review of computed tomography images alone.
  2. Addition of a standard anteroposterior pelvic radiograph with a pelvic binder.
  3. Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.

At each step, experts independently classified the injury (Arbeitsgemeinschaft für Osteosynthsesfragen / Orthopaedic Trauma Association and Young and Burgess classifications), assessed mechanical stability and recommended definitive treatment.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • admission to the author's institution between January 2012 and December 2023;
  • high-energy pelvic ring injury involving a non-pathologic pelvis (i.e., no prior injury, pathology, or surgery compromising image interpretation), surgically treated within three weeks of injury;
  • age ≥18 years at the time of trauma.

排除标准

  • imaging acquired after any kind of surgical stabilization (i.e. emergent external fixation), which could bias injury assessment;
  • incomplete imaging dataset, defined as the absence of any of the following: pelvic computed tomography, standard anteroposterior pelvic radiograph with pelvic binder, and standard anteroposterior pelvic radiograph without pelvic binder;
  • poor image quality, including incomplete pelvic coverage, computed tomography slice thickness >2 mm, motion artifacts, or incompatibility with the image viewer used for the study;
  • documented (written or verbal) refusal to participate.

结局指标

主要结局

Arbeitsgemeinschaft für Osteosynthesefragen / Orthopaedic Trauma Association (AO/OTA) classification

时间窗: From enrollment to the end of primary injury evaluation at day 1

Each expert determines the AO/OTA classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1. Review of computed tomography images alone; 2. Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3. Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.

Young and Burgess classification

时间窗: From enrollment to the end of primary injury evaluation at day 1

Each expert determines the Young and Burgess classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.

Pelvic ring mechanical stability assessment

时间窗: From enrollment to the end of primary injury evaluation at day 1

Each expert determines the mechanical stability of the pelvic ring injury (pelvic ring fully stable, pelvic ring horizontally unstable, pelvic ring fully unstable) presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided assessments is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of mechanical stability assessment.

Surgical fixation plan

时间窗: From enrollment to the end of primary injury evaluation at day 1

Each expert determines the surgical fixation plan (no fixation needed, anterior fixation only, posterior fixation only, lumboelvic fixation only, anterior and posterior fixation, anterior and lumbopelvic fixation) for the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided plans is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of surgical fixation planning.

次要结局

未报告次要终点

研究者

发起方
Axel Gamulin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Axel Gamulin

Dr Axel GAMULIN, MD, PD, CC, FMH, Senior Staff Surgeon

University Hospital, Geneva

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