NCT03519321Unknown不适用
Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Early Onset Scoliosis
Apifix1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maintenance of the major curvature ≤ 50 degrees at 24 months
研究概览
简要总结
Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years, regardless of etiology. It is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. Currently there are two basic treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for patients with a scoliosis of 35 to 75 degrees Cobb angle
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with EOS aged 6-11 years, including idiopathic, syndromic, congenital and low tone neuromuscular diagnoses.
- •Standing x-ray: a single major curve ≤ 8 vertebral segments, 35 to 75 degrees Cobb angle
- •"Normal" or hypokyphotic sagittal contour (T5-T12 ≤ 50⁰ degrees)
- •Primary curve should be reduced to < 35 degrees Cobb angle on lateral bending/traction/stretch x-ray- the residual rigid segment must be ≤ 35 degrees
- •Patients with ≤ 25 degrees trunk rotation based on Scoliometer measurement
- •Subject in good general health
- •Subject and both subject's guardians/legal representatives are willing to sign a written informed consent form
排除标准
- •EOS with more than one structural curve or a single curve involving more than 8 segments
- •High tone neuromuscular diagnoses
- •Primary curve cobb angle > 75 degrees
- •Kyphosis > 50 degrees
- •Previous scoliosis surgery
- •Neural axis abnormality observed by an MRI scan
- •Known allergy to titanium
- •Active systemic disease, such as AIDS, HIV, or active infection
- •Systemic disease that would affect the subject's welfare or overall outcome of the study.
- •Severely mentally compromised
结局指标
主要结局
Maintenance of the major curvature ≤ 50 degrees at 24 months
时间窗: 24 months
curve progression will be evaluated by X-ray as in the standard of care
次要结局
- Blood loss during surgery(Baseline - week 0)
- Duration of surgery(Baseline - week 0)
- No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits(6 months, 12 months, 24 months)
- Duration of hospitalisation(Baseline - week 0)
- No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits(6 months, 12 months, 24 months)
- Number of reoperations(6 Weeks, 3 months, 6 months, 12 months, 24 months)
研究者
研究点 (1)
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