Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Timed Up and Go (TUG) assessment
研究概览
简要总结
Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.
详细描述
This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and/or MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous screw fixation, or a nonoperative group, defined as treatment with physical therapy and pain management only.
- Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture
- Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >/= 60 years of age
- •Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
- •Low energy mechanism of injury or an insufficiency fracture without a precipitating event
- •Acute injury within four weeks of presentation
- •Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up & Go" (TUG) assessment, or inability to complete the TUG assessment.
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 injuries affecting ambulation
- •Presence of another injury or medical condition that prevents ambulation
- •Presence of implant or sacral morphology that prevents percutaneous sacral fixation
- •Enrollment in another research study the precludes co-enrollment
- •Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
- •Incarcerated or pending incarceration
研究组 & 干预措施
Operative
Percutaneous screw fixation
干预措施: Percutaneous screw fixation (Procedure)
Non-operative
Pain management and physical therapy advanced with weight bearing as tolerated.
干预措施: Pain management (Other)
Non-operative
Pain management and physical therapy advanced with weight bearing as tolerated.
干预措施: Physical therapy (Other)
结局指标
主要结局
Timed Up and Go (TUG) assessment
时间窗: Day 2 after treatment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.
次要结局
- Timed Up and Go (TUG) assessment(2 weeks, 6 weeks, and 3 months after treatment)
- Use of Narcotic Pain Medication(Day 2 after treatment)
- Sacral Region Pain by Visual Analog Scale(Day 2, 2 weeks, 6 weeks, and 3 months after treatment)
- Rate of Complications(2 weeks, 6 weeks, and 3 months after treatment)
- Hospital Length of Stay(Post discharge from treatment, an average of 5 days from being admitted to the hospital)
- Discharge Disposition Location(Post discharge from treatment, an average of 5 days from being admitted to the hospital)
- Longest Distance of Ambulation(Day 2 after treatment)