NCT04296903进行中（未招募）不适用
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
Apifix28 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2020年5月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
- 试验地点
- 28
- 主要终点
- Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
研究概览
简要总结
The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
- •Cobb angle between 35-60 degrees (inclusive);
- •Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
- •Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
- •Appropriate candidate for posterior surgical approach;
- •Patient has good general health;
- •Patient has no known hypersensitivity or allergies to titanium;
- •Patient's guardian signs a written informed consent form (ICF).
排除标准
- •Any type of non-idiopathic scoliosis;
- •Any main thoracic deformity that includes vertebral levels and cranial including to T2;
- •Known history of existing malignancy, or any systemic or local infection;
- •Spinal cord abnormalities that require treatment;
- •Known neurological deficit (defined as motor grade < 5/5);
- •Known poor bone quality defined as T score -1.5 or less;
- •For female Patient, pregnancy;
- •Previous spine surgery that would prevent the successful performance of the MID-C system ;
- •Active systemic disease, such as AIDS, HIV, or active infection;
- •Active infection or the skin is compromised at the surgical site;
- •Systemic disease that would affect the Patient's welfare or overall outcome of the study.
结局指标
主要结局
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
时间窗: 5 years
Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated
次要结局
未报告次要终点
研究者
研究点 (28)
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