Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of study-eligible subjects
研究概览
简要总结
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femur fracture distal to the femoral diaphysis.
- •Operative treatment within 72 hours of presenting to the treating hospital.
- •Patient was previously ambulatory.
- •Fracture amendable to either single or dual implant fixation.
- •Informed consent can be obtained from the patient, family member, or power of attorney.
排除标准
- •Associated major lower extremity fracture.
- •Ongoing infection.
- •History of metabolic bone disease (Paget's, etc).
- •Pathologic fracture.
- •Open fracture.
- •Severe cognitive impairment (Six Item Screener with 3 or more errors).
- •Stage 5 Parkinson's disease.
- •Significant femoral bone loss requiring planned staged bone grafting.
- •Vascular injury.
研究组 & 干预措施
Single Distal Femur Implant Group
Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.
干预措施: Single Distal Femur Implant (Procedure)
Dual Distal Femur Implant Group
Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.
干预措施: Dual Distal Femur Implant (Procedure)
结局指标
主要结局
Number of study-eligible subjects
时间窗: Baseline
Total number of subjects to be enrolled in the study
次要结局
- Early post-surgical complications(2 weeks post-surgery)
- Hospitalization days(approximately 2-3 days)
- Blood loss(Duration of surgery, approximately 2-4 hours)
- Operative times(Duration of surgery, approximately 2-4 hours)
研究者
Brandon James Yuan
Principal Investigator
Mayo Clinic