Isolated Locked Compression Plating Versus Cable Plating and Strut Allografts With Cerclage Wiring for Vancouver B1 Periprosthetic Femoral Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- TUG test score at 6 weeks post-op
研究概览
简要总结
The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in a faster return to function as measured by the TUG test at 6 weeks post-op.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: over 18, no upper limit
- •Vancouver type B1 periprosthetic fracture
- •Fracture is amenable to either treatment group
- •Prosthesis is well fixed
- •Provision of informed consent
排除标准
- •Presence of an active infection around the fracture (soft tissue or bone)
- •Loose prosthesis
- •Trauma patients with an ISS > 16 or associated major injuries of the lower extremities
- •Known substance abuse
- •Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)
研究组 & 干预措施
Cable plating with strut
The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut.
干预措施: Cable Plating and Strut Allograft with Cerclage Wiring (Procedure)
isolated plating
A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws.
干预措施: Isolated Locked Compression Plate (Procedure)
结局指标
主要结局
TUG test score at 6 weeks post-op
时间窗: 6 weeks
We will administer the TUG test to each patient at 6 weeks to determine if there is a difference in functional status between both groups.
次要结局
- Re-operation rates(1 year)