Single-center Comparative Study of Variation in Acetabular Anteversion According to Pelvic Tilt in Patients With Femoro-acetabular Impingement and Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Anteversions comparison
研究概览
简要总结
The main objective is to show that the upper acetabular anteversions calculated in standing, sitting, sitting hip in maximum flexion and supine positions are lower in patients with symptomatic DWI compared to healthy volunteers.
详细描述
The study will be presented to a population of symptomatic DWI patients who are offered hip arthroscopy. As these measurements have never been performed before in a control population, the study will also be proposed to a population of healthy volunteers, matched by age, sex, BMI and level of sports activity, in order to have comparative reference values.
The study consisted of cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions in both groups.
- Group 1: Symptomatic DWI patients
- Group 2: Healthy volunteers
For symptomatic patients, the preoperative workup will be the same as in routine practice and will include an X-ray as well as a CT scan. Low-dose EOS imaging of the pelvis in profile in 3 positions (standing sagittal tilt, sitting, maximum hip flexion) will complete this workup in the context of the study, to know the sacral slope associated with each of these positions. If the preoperative workup does not include a CT or arthroscan scan with measurement of femoral anteversion, it will be requested in the low-dose protocol.
The control group will perform a CT scan and EOS imaging in the same 3 positions as the patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for symptomatic patients:
- •Patient at least 18 years of age but < 50 years of age
- •Patient with a confirmed diagnosis of DWI for whom arthroscopic impingement surgery is proposed
- •Patient who has given and signed free and informed consent
- •A patient who is a member of a social security plan or a beneficiary of such a plan
- •Healthy volunteer inclusion criteria:
- •Person at least 18 years of age but < 50 years of age
- •Person with no existing DWI diagnosis
- •Person who has given and signed free and informed consent
- •Person affiliated with a social security plan or beneficiary of such a plan
排除标准
- •Patient who has already undergone surgery on the same hip
- •Patient with previous spine surgery
- •Patient already included in the study for the opposite hip
- •Pregnant or breastfeeding patient
- •Patient who did not give consent
- •Patient for whom it is impossible to give informed information
- •Mentally impaired or any other reason that may interfere with understanding
- •Patient under court protection, guardianship or curatorship
- •Patient in an exclusion period as determined by another study
结局指标
主要结局
Anteversions comparison
时间窗: Day 0
Comparison of anteversions of the superior plane of the acetabulum obtained from 3D CT reconstruction of the pelvis positioned standing, seated, seated hip in maximum flexion, and supine after matching by low-dose EOS X-ray images, between patients with symptomatic DWI and healthy volunteers.
次要结局
- Functional limitation(Month 24)
- Subject quality of life(Month 24)
- Postoperative satisfaction(Month 24)
- Return to previous activities(Month 24)