A Prospective, Randomized Controlled Trial Comparing Percutaneous Screw Fixation to Non-Operative Management for the Treatment of Sacral Fragility Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Timed Up and Go (TUG) Test
研究概览
简要总结
The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation to non-operative management for the treatment of symptomatic, sacral fragility fractures in elderly patients.
详细描述
Sacral fragility fractures cause significant pain and morbidity in the elderly population in which they occur. These low-energy pelvic injuries can cause prolonged immobility, long hospital stays, and requirement for higher levels of care.
Subjects will undergo a 48 hour period of physical therapy and pain management following identification of the sacral fracture.. If the subject has substantial pain or disability, the subject is eligible for enrollment in the RCT and randomization of 1:1 to one of two groups.
Group 1: Operative treatment: A single trans iliac trans sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.
Group 2: Conservative (non-operative) treatment: Continued pain management and physical therapy advanced with weight bearing as tolerated.
The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation to non-operative management for the treatment of symptomatic, sacral fragility fractures in elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 60 years of age
- •Pelvic ring fractures classified as LC1 or sacral U, confirmed with plain radiographs, CT and/or MRI
- •Fracture is the result of a low energy mechanism of injury or an insufficiency fracture without a precipitating event
- •Onset of symptoms within four weeks of presentation to hospital
- •Significant pain or disability determined by:
- •Reported pain score ≥ 7 using the Visual Analogue Score (VAS) after a Timed "Up & Go" (TUG) test, or
- •Inability to complete the TUG test
- •Inability to get out of bed secondary to pain for 2 consecutive days
排除标准
- •Vertically or rotationally unstable pelvic ring injuries
- •Pathologic fracture secondary to tumor
- •Non-ambulatory prior to injury
- •Acute neurologic deficit
- •High-energy mechanism of injury
- •Concomitant lower extremity fractures affecting ambulation
- •Presence of another injury or medical condition that prevents ambulation
- •Presence of hardware or sacral morphology that prevents percutaneous sacral fixation
- •Enrollment in another research study that precludes co-enrollment
- •Inability to speak English
- •Dementia with inability to answer questions and participate in study
- •Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)
- •Incarcerated or pending incarceration
结局指标
主要结局
Timed Up and Go (TUG) Test
时间窗: 2 weeks
TUG Test
Sacral Region Pain
时间窗: 2 weeks
Visual Analog Pain Scale, minimum score 0, maximum score 10, from no pain to worst possible pain
次要结局
- Complications(Up to 1 year)
- Ambulatory aid(2 weeks)
- Discharge Disposition Location(Up to 21 days)
- Facility Length of Stay(Up to 21 days)
- Patient Reported Outcome(Change from baseline to 1 year)
- Patient Reported Health Outcome(Change from baseline to 1 year)