A Multicentre, Randomized Trial of Far Cortical Locking Versus Standard Constructs for Acute, Displaced Fractures of the Distal Femur Treated With Locked Plate Fixation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Composite fracture healing
研究概览
简要总结
To determine if Far Cortical Locking screws increase fracture healing rates at 3 months in Closed Distal Femur Fractures in adults when compared to Standard screw constructs.
Fracture healing at 3 months will be assessed via radiographic and clinical assessment of the fracture.
Null Hypothesis: There will be no difference in fracture healing at 3 months post-fixation between subjects treated with far cortical locking screw or standard screw fixation.
详细描述
A multicentre randomized controlled trial with a sample size of 138 subjects.
Primary Outcome is fracture healing at 3 months via radiographic and and clinical assessment.
Radiographic healing will be defined as bridging of one or more cortices as seen on x-ray. Radiographic assessment will be centrally adjudicated by a committee of three study investigators.
Clinical healing will be assessed using the Function Index for Trauma (FIX-IT).
Secondary outcome measurements will include patient-reported quality of life and CT quantification of fracture callus volume.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composite fracture healing
时间窗: 3 months
Radiographic fracture healing defined as bridging of 1 or more cortices. Clinical fracture healing assessed with FIX-IT. Using the win ratio method, we hierarchically assessed radiographic healing, followed by clinical fracture healing. The pairwise comparison proceeds in a hierarchical fashion, using radiographic healing, followed by the FIX-IT score when patients cannot be differentiated based on radiographic healing. For each pairwise comparison, the treatment groups are assigned a win, loss, or tie. We calculate the win ratio as the number of wins in the FCL screw treatment group divided by the number of wins in the Standard screw group.
次要结局
- Patient-reported health-related quality of life(12 months)
- CT quantification of fracture callus volume(3 months)
- Radiographic healing(3 months)
- Clinical healing(3 months)
研究者
Kelly A. Lefaivre
Principal Investigator
University of British Columbia