Pelvic Inclination Measurement by Navigated Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Pelvic inclination measurement
研究概览
简要总结
Prospective, multicenter, non-randomized study.
Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls.
Secondary endpoint : to describe the values of pelvic inclination while standing, sitting and lying in patients with severe hip osteoarthritis before and after total hip arthroplasty
After signing the inform consent form:
For the first endpoint (, 3 healthy volunteers of different morphotypes will have one consultation comprising :
- a medical examination
- 10 measurements of pelvic inclination in sitting position, 10 measurements of pelvic inclination in supine position and 10 measurements of pelvic inclination in standing position, each realized per three different operators. These measurements will be carried out with navigated ultrasound.
For the secondary endpoint, 30 patients awaiting for a hip replacement surgical intervention will realized one consultation the day before the intervention, and one consultation at 2 months after surgery, each comprising :
- a medical examination
- 3 measurements of pelvic inclination (1 standing, 1 sitting and 1 supine). These measurements will be carried out with navigated ultrasound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For primary endpoint
- •* No medical or surgical history
- •* Major healthy voluntary topic with
- •* Body Mass Index (BMI) \<20 for a subject
- •* 24 \ 30 for a subject
- •* Subject having signed an informed consent
- •For the secondary endpoint
- •* Adult patient requiring total hip arthroplasty for severe hip osteoarthritis
- •* Patient having signed an informed consent
排除标准
- •Minor subject
- •Resumption of total hip prosthesis
- •Subject who can not express their consent to research
- •Presence of medical or surgical history for healthy volunteers
研究组 & 干预措施
Healthy volunteers
- a medical examination
- 10 measurements of pelvic tilt in sitting position, 10 measurements of pelvic tilt in supine position and 10 measurements of pelvic tilt in standing position, each performed by three different operators. These measurements will be done by ultrasound.
干预措施: Pelvic inclination measurement (Other)
Patients
a consultation the day before surgery, and a consultation 2 months after surgery, each including:
- a medical examination
- 3 pelvic tilt measurements (1 standing, 1 sitting and 1 lying down). These measurements will be done by ultrasound.
干预措施: Pelvic inclination measurement (Other)
结局指标
主要结局
Pelvic inclination measurement
时间窗: Day 0
The pelvic inclination measurement corresponds to the anterior pelvic plane also known as the Lewinnek's plane; defined by the plane between both anterior superior iliac spine and the pubic symphysis. A Portable Ultrasound based Device is used for the Measurement of the Pelvic Tilt
次要结局
- Variation of pelvic inclination before and after hip replacement(Month 2)