Quantitative Stress Radiography With Pelvic Binder for Evaluation of Instability in Lateral Compression Pelvic Ring Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Pelvic fracture displacement at 5 kg of stress
研究概览
简要总结
The primary aim of this investigation is to prospectively and clinically validate a novel, reproducible method of quantitative application of compressive stress to a LC1 pelvic ring injury of indeterminate stability for the purpose of assessing quantitative pelvic ring displacement.
详细描述
patients will receive a diagnostic intervention with multiple x-rays. These x-rays will be taken as different levels of force are applied to the pelvis. This will be used to determine instability as an indication for surgical intervention to stabilize the pelvic ring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Acute emergency department admission or transfer to Los Angeles County + USC Medical Center
- •Presentation within 3 weeks of injury
- •Blunt or blast mechanism of traumatic injury
- •Lateral compression pelvic ring injury with unilateral incomplete disruption of the posterior arch (OTA/AO 61B1.1/2.2; Young Burgess LC1) on radiographs and/or computed tomography scan of the pelvis obtained per routine care
- •LC1 pelvic ring injuries occurring in isolation are virtually never associated with hemodynamic instability or critical patient condition
- •Stress examination of LC1 pelvic ring injury is standard of care
- •Patient must speak either English or Spanish
排除标准
- •Volume expanding pelvic ring injury (Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C).
- •Volume expanding pelvic ring injury injuries represent the types of pelvic ring disruption responsible for pelvic hemorrhage and hypotension and are correlate with patient hemodynamic instability as well as critical injuries
- •Volume expanding pelvic ring injury injuries warrant stabilization with circumferential pelvic compression.
- •Patients with volume expanding pelvic ring injury are not clinically appropriate for this study.
- •Hemodynamic instability or hypotension angioembolization (AE), preperitoneal pelvic packing (PPP), or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) to obtain or maintain hemodynamic stability
- •Bladder, vaginal, rectal, colonic, or other abdominal or pelvic organ injury precluding safe application of circumferential pelvic compression device
- •Patient likely to have severe problems with maintaining follow- up due to at least one of the following:
- •Patient has been diagnosed with a severe psychiatric condition
- •Patient is intellectually challenged without adequate family support
- •Patient lives outside the hospital's catchment area
- •Follow-up is planned at another medical center
- •Patients who are prisoners or homeless
结局指标
主要结局
Pelvic fracture displacement at 5 kg of stress
时间窗: At diagnostic intervention, immediately following baseline data collection.
Linear displacement of the pelvis fracture defined as the difference in distance measured at the acetabular teardrops on a pelvis inlet radiograph with no applied stress and a pelvis inlet radiograph with 5 kg of stress applied with the pelvic binder.
Pelvic fracture displacement at 10 kg of stress
时间窗: At diagnostic intervention, immediately following baseline data
Linear displacement of the pelvis fracture defined as the difference in distance measured at the acetabular teardrops on a pelvis inlet radiograph with no applied stress and a pelvis inlet radiograph with 10 kg of stress applied with the pelvic binder.
次要结局
未报告次要终点
研究者
Joseph Patterson
Assistant Professor
University of Southern California