Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Cobb angle measurement
研究概览
简要总结
This is a randomized trial with 1:1 allocation. The aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (MIS) technique versus posterior spinal fusion (PSF) technique through clinical and radiographic evaluations.
详细描述
Patients with developmental age idiopathic scoliosis will be included in a randomized trial in which one group of patients will be treated with mini invasive scoliosis surgery technique , and one group will be treated instead with traditional posterior spinal fusion arthrodesis. The study design involves a noninferiority evaluation, assuming that MIS does not produce inferior results to the classic technique from the point of view of curve correction. This result would be important, because with equal curve correction success, the risk/benefit balance for minimally invasive surgery is superior, as it reduces the risk of transfusion and postoperative pain. The results of this study could therefore give important guidance for surgeons on choosing the optimal treatment for patients.
Patients will be evaluated by clinical examination, before the surgical procedure and at subsequent follow-ups as per clinical practice: at 2, 6, 12, 24, 60 months after treatment by medical personnel.
During the selection visit, patients will also be evaluated with radiographic examination for measurements necessary to decide the indication for surgical treatment. The patient also undergoes postoperative radiographic examination before discharge, as well as at follow-ups at 2, 6, 12, 24, and 60 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AIS
- •Age between 12 and 25 years;
- •Site of scoliotic curve: thoracic and/or lumbar;
- •Preoperative radiographic range of the main scoliotic curve between 40° and 70° according to Cobb;
- •Ability and consent of patients/parents to actively participate in the study and clinical follow-up.
排除标准
- •Patients already treated surgically for scoliosis;
- •Site of the scoliotic curve: cervical;
- •Patients with scoliosis other than adolescent idiopathic scoliosis;
- •Patients who do not fall within the described parameters;
- •Unbalanced sagittal profile;
- •Patients unable to consent or perform follow-ups.
- •Pregnant women.
结局指标
主要结局
Cobb angle measurement
时间窗: 12 months follow-up
Cobb's angle represents the gold standard for measuring the extent of the scoliotic curve; it is identified as the angle between the two lines passing through the upper limiting vertebra and the lower limiting vertebra on an antero-posterior radiogram of the spine.
次要结局
- NRS (Numeric Rating Scale)(baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up)
- Cobb angle measurement(baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up)
- Screw malposition rate(6 months)
- SRS-22 (Scoliosis Research Society-22)(baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up)
- Oswestry Disability Index (ODI)(baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up)
- Final treatment opinion(2 months, 6 months, 12 months, 24 months and 60 months follow-up)
- Incidence of mechanical complications(2 months, 6 months, 12 months, 24 months and 60 months of follow-up)
- Intraoperative and immediate postoperative outcomes(through study completion, up to 5 years)