Using Ultrasound as an Alternative to Radiography in Measuring Magnetically Controlled Growing Rods (MCGR) in Tibia and Femur Lengthening Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Ultrasound Measurement of the lengthening rod
研究概览
简要总结
The goal of this clinical trial is to learn if an ultrasound can measure the length of an internal tibia and femur lengthening rod. The main questions it aims to answer are:
Can an ultrasound be used to measure the length of an internal magnetic lengthening nail in a tibia or femur? Can an ultrasound measure the rod lengthening as well as an ultrasound? Researchers will compare the length of an internal magnetic lengthening rod with both x-rays and ultrasound
Participants will:
Have standard x-rays every week They will also have an ultrasound of the femur or tibia
详细描述
Limb lengthening with expanding intramedullary rods has become the standard of care for limb lengthening procedures. The procedure entails performing an osteotomy of the short bone and placing a mechanical expanding intramedullary nail. The aim of the study is to explore the role of ultrasound to measure tibia and femur lengthening procedures and compare the accuracy to standard radiographs.
The study design is a prospective, pilot study of 5 tibias and 5 femurs. Measurements of the femurs and tibias will be obtained in 3 separate locations to try to identify areas that can be visualized and measured by an ultrasound. The cost of the ultrasound will be compared to the cost of x-rays, and any pain regarding imaging modalities will also be compared
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing tibia or femur lengthening with an intramedullary mechanical rod.
排除标准
- •Patients who underwent lengthening procedure with any other device such as external fixator.
- •Patients under 8 years old and over 21 years of age
研究组 & 干预措施
Ultrasound of lengthening rod
All patients will have an ultrasound measuring the lengthen of the internal rod
干预措施: X-ray imaging of tibia and/or femur (Diagnostic Test)
Ultrasound of lengthening rod
All patients will have an ultrasound measuring the lengthen of the internal rod
干预措施: ultrasound measurement (Device)
结局指标
主要结局
Ultrasound Measurement of the lengthening rod
时间窗: Once a week during the lengthening process, up to 10 weeks
ultrasound measurement of the length of the internal lengthening rod
X-ray measurement of the lengthening rod
时间窗: Once a week during the lengthening process, up to 10 weeks
X-ray measurement of the internal lengthening rod at three points on the rod.
次要结局
- Cost of imaging(Once a week during the lengthening process, up to 10 weeks)
- Pain reported during imaging(Once a week during the lengthening process, up to 10 weeks)
研究者
Jason Malone
Pediatric Orthopedic Surgeon
Nemours Children's Clinic