Globus Reflect Tether - Humanitarian Use Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 主要终点
- Cobb angles
研究概览
简要总结
The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. In patients with a curvature about the spine, Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.
详细描述
The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. This device received an HDE exemption from the FDA and requires MUSC IRB approval to be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 35 to 60 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
- •Patients should have failed bracing and/or be intolerant to brace wear.
排除标准
- •Pregnancy (current)
- •Prior spinal or chest surgery
- •MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
- •Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
- •Associated syndrome, including Marfan Disease or Neurofibromatosis
- •Sanders stage greater than 4
- •Thoracic curve less than 35 or greater than 60
- •Lumbar curve greater than or equal to 35
- •Unable or unwilling to firmly commit to returning for required follow-up visits
- •Investigator judgement that the subject/family may not be a candidate for the intervention
结局指标
主要结局
Cobb angles
时间窗: Until patients reach the age of 18
Decrease in cobb angles for patients who are actively still growing
次要结局
未报告次要终点