Evaluation of Surgical Treatment of Idiopathic Scoliosis With Vertebral Body Tethering (VBT) Versus Posterior Spinal Fusion (PSF).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Surgical scoliosis correction
研究概览
简要总结
The aim of this study is to evaluate the short, medium and long-term efficacy and safety of vertebral body tethering, based on the results obtained at 3-5 months of follow-up, exploring not only the ability to correct scoliosis, but also the safety and ability to preserve the natural motility of the spine. To this end, the geometric and kinematic parameters of the spine through gait analysis, both during the execution of motor tasks such as walking at a flat level, and in static, upright posture and during the execution of elementary trunk movements will be analyzed, comparing patients undergoing vertebral body tethering and posterior spinal fusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with adolescent idiopathic scoliosis who underwent surgical correction using posterior spinal fusion or vertebral body tethering from 2019 to 2022 and provided informed consent;
- •Males or females aged 12 to 18 years at the time of surgery;
- •Sanders skeletal maturation age ≤ 6;
- •Thoracic scoliotic curve ≥ 40° COBB and ≤ 60° COBB, measured on upright full spine x-rays, anterior-posterior pose.
排除标准
- •Patients who had previously undergone spinal or thoracic surgery prior to adolescent idiopathic scoliosis correction;
- •Surgically treated patients with scoliosis of a non-idiopathic etiology;
- •Patients with anamnestic, clinical, and radiographic characteristics that do not fall within the indication window for the surgical technique of vertebral body tethering;
- •Patients with severe intramedullary malformations (syringomyelia greater than 4 mm, Chiari malformation, or tethered cord);
- •Structured scoliotic lumbar curve > 35°, as measured by Cobb radiography.
- •Patients who do not provide informed consent to the study.
研究组 & 干预措施
posterior spinal fusion
Scoliosis patients undergoing traditional surgical treatment, using posterior spinal fusion.
干预措施: gait analysis (Procedure)
vertebral body tethering
Scoliosis patients undergoing surgical treatment with vertebral body tethering, a technique that involves inserting screws into the vertebral bodies on the convex side of the scoliotic curve, via thoracoscopic access; the screws are then connected to a band, which, when tensioned, shortens the convex side of the scoliosis.
干预措施: gait analysis (Procedure)
结局指标
主要结局
Surgical scoliosis correction
时间窗: 4 years after surgery
measurement of cobb angle after surgery
Gait Analysis
时间窗: 4 years after surgery
Evaluation of the preservation of spinal functionality at an average of 48 months after surgical correction of scoliosis, through the measurement and correlation of geometric and kinematic parameters of the trunk and spine using instrumental movement analysis, by measuring the relative angles between segments of the spine and trunk, following the protocol of Leardini et al. 2011
次要结局
- Interoperative complications(4 years after surgery)
- Range of Motion(4 years after surgery)