NCT04992845终止不适用
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
Spino Modulation Inc.1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Cobb angle measurement
研究概览
简要总结
The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.
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
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of juvenile or adolescent idiopathic scoliosis
- •Male and female subjects greater than 8 years of age with significant growth remaining
- •Risser Stage 0 or 1
- •Subjects should have at least three years of estimated growth remaining based on Risser staging
- •Major thoracic scoliosis with Cobb Angle > 40° and < 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure
- •Thoracic kyphosis (T5-T12) < 50°
- •Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)
- •Menses < 4 months
- •Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations
- •Subject assent and parent/legal guardian consent obtained and documented.
排除标准
- •Scoliosis curve is less than 30° or more than 70°
- •Thoracic kyphosis is greater than or equal to 50° (T5-T12)
- •The vertebrae to be instrumented is less than 12mm in height (based on the staple size)
- •One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length)
- •One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length)
- •Non-idiopathic scoliosis
- •Non-ambulatory
- •Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease
- •Prior thoracic surgery
- •Abnormal neurological status at baseline
- •Any condition or therapy that the investigator believes might pose a risk to the participant or make participation in the study not in the participant's best interest
结局指标
主要结局
Change in Cobb angle measurement
时间窗: 12 months
The change in Cobb angle measurement from baseline (preoperative) to 12 months
Rate of device- &/or procedure-related SAEs
时间窗: 12 months
Rate of positively adjudicated device or procedure related serious adverse events including subsequent secondary surgical intervention and neurological events from baseline (preoperative) through 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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