NCT03870477终止不适用
Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 6
- 主要终点
- Number of Participants With a Revision
研究概览
简要总结
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
详细描述
Primary Endpoint:
• Revision rate due to device related complication(s) or non-union of the femur.
Secondary Endpoints:
• Radiographic and clinical fracture healing of the proximal femur using standard scoring methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient must be 18 years of age or older.
- •Patient must be eligible for an open reduction and internal fixation of the proximal femur.
- •Patient must have an intracapsular or intertrochanteric fracture.
- •Patient must have need for alignment, stabilization, and reduction of bone fractures.
- •Patient must have ability and willingness to follow postoperative care instructions until healing is complete.
- •Patient must be in good nutritional state.
- •Patient must be able and willing to sign the IRB/EC approved informed consent.
排除标准
- •Patient is a prisoner.
- •Patient is a current alcohol or drug abuser.
- •Patient is known to be pregnant or breastfeeding.
- •Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent.
- •Infection.
- •Patient conditions including bloody supply limitations, obesity or insufficient quantity or quality of bone.
- •Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- •Patient has foreign body sensitivity. Where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
- •Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
结局指标
主要结局
Number of Participants With a Revision
时间窗: 6 weeks
Revision rate due to device related complication(s) or non-union of the femur.
次要结局
- Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)(6 weeks)
- Average FIX-IT Score (Clinical Fracture Healing of the Femur)(6 weeks)
- Average VAS Pain Score(6 weeks)
- Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)(6 weeks)
研究者
研究点 (6)
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