NCT03603470已完成不适用
Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年7月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Sacral slope between standing to sitting difference between groups
研究概览
简要总结
The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no history of instability.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient must be at least 18 years old and less than 85 years old
- •Patient has a conventional first intention total hip arthroplasty (not dual mobility) by posterior approach
- •"Case" patients have at least one previous episode of prosthetic dislocation repaired with surgery
- •"Control" patients have no previous episode of prosthetic dislocation with more than 2 year since initial intervention
排除标准
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient is pregnant, parturient or breastfeeding
- •Patient with lumbar instrumentation
- •Patient with severe dementia (Mini Mental State Examination < 10)
- •Patient with American Society of Anesthesiologists score ≥ 4
- •Patient experience multiple falls
- •Patient requiring early revision surgery (<15 days postoperatively
- •Patient with obvious implant positioning error on an X-ray of the pelvis.
- •Patient with dislocation of traumatic origin (significant kinetic trauma)
结局指标
主要结局
Sacral slope between standing to sitting difference between groups
时间窗: Day 0
Sacral slope between standing to sitting difference between groups
Rate of type 1 pelvic kinematic disorder between groups
时间窗: Day 0
Measured by sacral slope difference from standing to seated position \< 12°.
次要结局
- Lumbar lordosis between standing and seating between groups(Day 0)
- Lewinnek plane (Anterior pelvic plane) between standing and seating between groups(Day 0)
- Classification of patients' pelvic kinematic disorder (Type 1 or 2)(Day 0)
- Femoroacetabular flexion between standing and seating between groups(Day 0)
- Pelvic version between standing and seating between groups(Day 0)
- Classification of patients according to pelvic incidence(Day 0)
- Classification of patients according to sagittal imbalance(Day 0)
- Classification of patients according to sacral slope(Day 0)
- Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting(Day 0)
研究者
研究点 (4)
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