Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery
研究概览
简要总结
The purpose of this study is to determine the effect of double end spinal instrumentation from the upper thoracic to the pelvis with sacro-iliac fixation on the gait of ambulating patients with pelvic obliquity 6 month after surgery.
详细描述
The pelvic fixations were used since many years for these patients. However there are no prospective study investigating the gait evolution before and after a surgical treatment by long spinal instrumentation with pelvic fixation.
Investigators are planning to analyze the gait, before and 6 months after surgery. Investigators will use 2 qualitative criterions with a gait analysis and a walking test, and 1 quantitative criterion with a questionnaire assessing the patient's functional change. Investigators will use as surgical treatment a long double end spinal fixation without fusion, investigators use an ilio sacral screw as pelvic anchor on each side.
Evaluation of changes in gait after pelvic fixation of a long spinal instrumentation will make it possible to extend or, on the contrary, restrict the indications for pelvic fixation surgery in walking patients, who are candidates for pelvic fixation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient under 18 walking or strolling
- •Patient with scoliosis requiring long instrumentation taking pelvis with iliosacral screws
排除标准
- •Patient presenting a predictable pejorative evolution of the walk due to the pathology of the patient within 2 years
- •Patient or parent who has notified their refusal to participate
结局指标
主要结局
Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery
时间窗: 6 months before and 6 months after spinal surgery
to assess the quality criteria of walk
Change in Clinical Gait Analysis from 6 months before spinal surgery at 6 month after spinal surgery
时间窗: 6 months before and 6 months after spinal surgery
to assess the quantitative criteria of walk
Change in 6-minute walking test from 6 months before spinal surgery at 6 month after spinal surgery
时间窗: 6 months before and 6 months after spinal surgery
to assess the quantitative criteria of walk
次要结局
- Change in "holding of the head " of scoliosis : from 6 months before spinal surgery at 6 month after spinal surgery(6 months before and 6 months after spinal surgery)
- presence / absence of cardiac impairment(6 months before spinal surgery)
- presence / absence of neurological impairment(6 months before spinal surgery)
- Change in imbalance of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery(6 months before and 6 months after spinal surgery)
- presence / absence of respiratory impairment(6 months before spinal surgery)
- Change in curvature of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery(6 months before and 6 months after spinal surgery)
- Change in reducibility of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery(6 months before and 6 months after spinal surgery)