Comparison of the Incidence of Cut-out Between Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of cut-out.
研究概览
简要总结
The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).
Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate.
详细描述
Randomized, open and prospective clinical trial.
Following the surgical indication for open reduction and internal fixation as treatment for proximal femoral fractures, patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: a Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.
Experimental group: a Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment.
- •Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties.
排除标准
- •Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture.
- •Subcapital fracture of the proximal femur.
- •Subtrochanteric fracture of the proximal femur.
- •Pathological fracture.
研究组 & 干预措施
Single Cephalic Screw System
A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.
干预措施: Gamma 3 Nail (Stryker) (Device)
Double Cephalic Screw System
A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
干预措施: Chimaera Nail (Orthofix) (Device)
结局指标
主要结局
Incidence of cut-out.
时间窗: 0-6 months
Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head.
次要结局
- Number of Surgical complications (post-operative)(0-6 months)
- Baumgaertner reduction quality criteria(3-6 months)
- Number of Surgical complications (Intraoperative)(0-1 month)
- Functional Ambulatory Categories (FAC)(0-6 months)
- Tip-apex distance(3-6 months)
- Parker index(3-6 months)
研究者
Pedro-José Torrijos-Garrido
Principal Investigator
Puerta de Hierro University Hospital