Multicenter Study on the Contribution of Surgical Treatment by ST2R Technique (Simultaneous Translation on Two Rods) in Scoliosis of the Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 10
- 主要终点
- Assessment radiographically of the dimensional scoliosis correction in the coronal plan
研究概览
简要总结
Although practiced for many years, surgical correction of scoliosis is relatively subject published for idiopathic scoliosis and a few published for other types of scoliosis.
This study involves a creation of an observatory of patients undergoing scoliosis by ST2R reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system.
The main objective is to analyze the three-dimensional correction of the deformity after intervention and its maintenance over time depending on the etiology of scoliosis.
This research is conducted in pediatric surgery services specialized in this technique.
Correcting radiographic parameters is directly related to the surgical procedure. The quality of life of patients is indirectly affected by the surgery. Secondary objectives are to analyze the surgical technique and to evaluate its impact on the quality of life of patients.
This study will firstly to have a better understanding in:
- Scoliosis of the children and adolescents and their surgical treatment;
- The impact of the surgical procedure by the ST2R technique on the three-dimensional correction, and the patient's quality of life; and secondly, better management of patients requiring surgery for scoliosis as well as a public health impact.
详细描述
The correction of the deformity in three planes of space is the main goal of surgical treatment of children's scoliosis and adolescents.
The techniques provide a satisfactory correction of the deformity in the coronal plane but remain insufficient in the sagittal plane and in particular for the correction of thoracic hypokyphosis.
Dr. Clarke and his team have shown that ST2R reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system gave a good correction of the thoracic hypokyphosis of idiopathic scoliosis. The results of his single-center studies have shown that ST2R technique allowed to restore normal thoracic kyphosis with an average gain of 23 ° in patients preoperatively hypokyphosis, higher than the gains made by other techniques (rotation of the shaft, close off Gradually, in situ bending), while providing a frontal correction 70%, similar to results reported by other techniques. The results of this technique for non idiopathic scoliosis are still to be analyzed.
The creation of an observatory of children's and adolescents scoliosis (idiopathic, neuromuscular, etc ...) operated by the technique of reduction by simultaneous translation on two rods with the same instrumentation will:
- Firstly, to confirm or refute the first published results idiopathic scoliosis
- And secondly to analyze the results of the same technique on all other scoliosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scoliosis of the children and adolescents requiring surgical treatment by the technical ST2R
- •Non-opposition form signed by the patient in a state to consent
- •Non-opposition form signed by at least one of the legal representatives
- •Children affiliated to the Social Security system
排除标准
- •All cases that do not require surgical treatment by the technical ST2R
- •Malformation or vertebral fractures
- •All patients not willing to comply with instructions postoperative
- •Opposition by the patient or legal guardian with the use of pre- and postoperative data
- •Not affiliated to the Social Security system
结局指标
主要结局
Assessment radiographically of the dimensional scoliosis correction in the coronal plan
时间窗: 60 months after chirurgical intervention
Cobb angle measurements of curvatures
次要结局
- Assessment radiographically of the dimensional scoliosis correction in the sagittal plan(60 months after chirurgical intervention)
- Assessment of the patient's quality of life(60 month after the chirurgical intervention)
- Assessment of scoliosis in preoperative(baseline)
- Assessment of the postoperative complications(60 month after the chirurgical intervention)
- Assessment radiographically of the dimensional scoliosis correction in the coronal plan(5 minutes after the end of the chirurgical intervention)
- Assessment radiographically of the dimensional scoliosis correction in the axial plan(60 months after chirurgical intervention)
- Assessment of the intra operative complications(5 minutes after the end of the chirurgical intervention)