Post-market Clinical Follow-up Study of NEMOST V2 Growing Domino
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Complication rate
研究概览
简要总结
The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children.
As part of post-market surveillance, EUROS is conducting a retrospective and prospective study to collect clinical and radiological data on the NEMOST growth domino.
Retrospective and prospective multicenter post-market surveillance clinical study.
This study is interventional, non-randomized, and uncontrolled. The primary objective of this clinical study is to monitor complications related to the NEMOST growth domino during a 5-year postoperative follow-up in patients treated for progressive scoliosis in children.
The secondary objective of this clinical study is to monitor the performance of the NEMOST growth domino during a 5-year postoperative follow-up in patients treated for progressive scoliosis in children.
The study will include 140 patients.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic, congenital, neuromuscular, or syndromic scoliosis : Progressive spinal deformity not managed by orthopedic treatment, and requiring primary surgical intervention.
- •The patient, as well as their parents or legal guardians, are informed of the participation in the study.
- •Patients aged from 5 to 17 yeas old, excepted the one who still have a potential for growth
排除标准
- •signs of local inflammation;
- •acute or chronic, local or systemic infections ;
- •non-reducible scoliosis ;
- •pathological obesity ;
- •allergy or intolerance to implanted materials;
- •insufficiency or absence of tissue coverage. The NEMOST implant should not be used in a spine that has already been instrumented or fused.
研究组 & 干预措施
NEMOST V2
干预措施: NEMOST V2 growing domino (Device)
结局指标
主要结局
Complication rate
时间窗: 5 years
The safety of the device will be studied by monitoring all complications, reinterventions and revisions.
次要结局
- Cobb angle (°)(5 years)
- Early-Onset Scoliosis questionnaire 24 items (EOSQ-24)(5 years)
- Pelvic obliquity (°)(5 years)
- Thoracic kyphosis (°)(5 years)
- Lumbar lordosis (°)(5 years)
- T1-T12 and T1-S1 length (mm)(5 years)
- Respiratory functional exploration(5 years)