External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Time to Definitive Surgery
研究概览
简要总结
Aim:
- Determine if external fixation decreases soft tissue complications compared to splinting.
- Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting.
- Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems.
Hypothesis:
- External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting
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
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary consent
- •Age 18 to 69
- •Clinical and/or advanced imaging confirming an acute calcaneal fracture that has occurred within 2 days of which, eventually definitive surgery is recommended/accepted.
- •Unable to consent
排除标准
- •Prior surgery of the affected extremity
- •Prisoners
- •Pregnant women
- •Inflammatory arthritis
- •Non-English-speaking patients
研究组 & 干预措施
External fixation
Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.
干预措施: External fixator (Procedure)
Splinting
Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.
干预措施: Splinting (Procedure)
结局指标
主要结局
Time to Definitive Surgery
时间窗: Within 2 weeks from injury
Duration of time from injury to definitive surgery
Soft Tissue Complications
时间窗: Assessed at 24 months after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
时间窗: Assessed at 2 weeks after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
时间窗: Assessed at 6 weeks after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
时间窗: Assessed at 12 weeks after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
时间窗: Assessed at 6 months after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
时间窗: Assessed at 12 months after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
次要结局
- Radiographic Parameters - Calcaneal Height(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)
- Radiographic Parameters - Calcaneal Width(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)
- Functional Outcomes - FAAM ADL(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)
- Radiographic Parameters - Bohler's Angle(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)
- Union Rate(Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.)
- Functional Outcomes - VAS(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.)
- Functional Outcomes - FAAM Sport(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)
- Radiographic Parameters - Angle of Gissan(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)
- Radiographic Parameters - Calcaneal Length(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)
- Functional Outcomes - FFI-R(Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery)