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
- 1
- 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
- •Specific inclusion criteria:
- •Men or women ages 18 years or older
- •Displaced distal femur fracture (OTA 33A or 33C) as seen in radiographs
- •Planned treatment using a distal femur locking plate
- •Ability to read and speak English or availability of translator willing to assist with completion of study forms
- •Fractures < 14 days post injury
- •Provision of informed consent
排除标准
- •Open distal femur fracture requiring flap or vascular repair (grade 3b or 3c)
- •Planned fixation strategy includes interfragmentary lag fixation of non-articular fractures
- •Active local infection
- •Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
- •Inability to comply with rehabilitation or form completion
- •Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
- •Non-ambulatory patients
- •Lack of bone substance or poor bone quality which, in the surgeon's judgment, makes locked plate fixation impossible
- •Periprosthetic fractures
- •Any concomitant lower-extremity injury that requires non-weight-bearing beyond 6 weeks post-operative
- •Addition of bone graft, bone graft substitute or BMP
- •Pregnant women
研究组 & 干预措施
Far Cortical Locking screw fixation
Far Cortical Locking screw fixation
干预措施: Far Cortical locking screw fixation (Device)
Standard screw fixation
Standard screw fixation
干预措施: Standard screw fixation (Device)
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)
- Patient-reported health-related quality of life(3 months)
研究者
Kelly A. Lefaivre
Principal Investigator
University of British Columbia