NCT03807349终止不适用
N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Number of Participants With a Reoperation
研究概览
简要总结
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
详细描述
Primary Endpoint:
• Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Secondary Endpoints:
- Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction.
- Cost effectiveness
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
- •Patient receives operative treatment within 7 days of injury.
- •Patient was ambulatory before injury.
- •Patient is 50 years of age or older.
排除标准
- •Patient has Garden III or IV intracapsular proximal femur fracture.
- •Patient has major cognitive impairment (including dementia).
- •Patient is on dialysis.
- •Patient is not expected to survive follow-up schedule.
- •Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
- •Patient is a prisoner.
- •Patient is known to be pregnant and/or breastfeeding.
- •Patient is a known alcohol or drug abuser.
- •Patient had previous/has active acute or chronic infections, especially at the site of operation.
- •Patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant.
- •Patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected.
- •Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
- •Physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede healing.
结局指标
主要结局
Number of Participants With a Reoperation
时间窗: 12 months
Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
次要结局
- Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)(6 weeks, 3 months, 6 months, and 12 months)
- Cost-Effective Analysis(12 months)
- Participant Steinberg Classification at 12 Months(12 months)
- Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)(6 weeks, 3 months, 6 months, and 12 months)
- Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)(6 weeks, 3 months, 6 months, and 12 months)
- Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)(6 weeks, 3 months, 6 months, and 12 months)
- Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)(6 weeks, 3 months, 6 months, and 12 months)
- Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)(6 weeks, 3 months, 6 months, and 12 months)
研究者
研究点 (8)
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