PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Viability of the femoral head as assessed by fluoride uptake using PET-CT
研究概览
简要总结
This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.
详细描述
Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.
The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
- •Healthy contralateral hip
- •ASA (American Society of Anesthesiologists) Physical Status Class I or II
排除标准
- 未提供
研究组 & 干预措施
Standard Nail
Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).
干预措施: PFN-A Nail (Procedure)
Augmented Nail
Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+
干预措施: Cement augmentation (Procedure)
Augmented Nail
Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+
干预措施: PFN-A Nail (Procedure)
结局指标
主要结局
Viability of the femoral head as assessed by fluoride uptake using PET-CT
时间窗: 4 months postoperatively
The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.
次要结局
- Harris Hip Score(1 year)
- Viability of the femoral head as assessed by fluoride uptake using PET-CT(1 year postoperatively)