NCT00552331已完成4 期
Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Delayed union or nonunion of the distal femur
研究概览
简要总结
The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has read and agree to the consent
- •Patient is 16 years or older (bones have finished growing)
- •The injury happened in the last 14 days
排除标准
- •The patient taking part in another study
- •The patient has an infection at the operative site
- •The patient has a health condition that affects bone healing or interferes with their ability to complete the study requirements (questionnaires, examinations), for example Paget's disease or osteomalacia
- •The patient is taking medication that affects bone healing (such as systemic steroids)
- •The patient has malignant (tumor) disease
- •The patient is unable to attend follow-up clinic visits
结局指标
主要结局
Delayed union or nonunion of the distal femur
时间窗: 12 months post operative
Determined via radiographic analysis
次要结局
- Time to clinical healing(12 months)
- Function as assessed by patient(6 months, 12 months)
- Frequency of adverse events(12 months)
- Range of motion(Post-op, 6 weeks, 3 months, 6 months, 12 months)
- Gait analysis(12 months)
研究者
研究点 (2)
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