Post-approval Study to Evaluate the Continued Safety and Efficacy of the MID-C System 5 Years Post-implantation in Adolescent Idiopathic Scoliosis (AIS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Safety endpoint
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. A total of 10 patients, who are planned to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the MID-C 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
- 10 Years 至 18 Years（Child, 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;
- •Patients with Risser stage 0-1, primary Cobb angle between 35-50 degrees (inclusive), or
- •Patients with Risser stage 0-1 and good brace compliant but curve progression above 6°, or
- •Patients with Risser stage 0-1 that are non-compliant with brace treatment and primary Cobb angle between 30-50 degrees or
- •Patients with Risser stage 2, primary Cobb angle between 40-50 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 ≤ 45 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;
- •Cumulative vertebral wedging over the apex of the curve>15º
- •Known history of existing malignancy, or any systemic or local infection;
- •Spinal cord abnormalities that require treatment;
- •Known neurological deficit (defined as motor grades < 5/5);
- •Known poor bone quality defined as T score -1.5 or less;
- •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; and
- •Systemic disease that would affect the patient's welfare or overall outcome of the study
结局指标
主要结局
Safety endpoint
时间窗: 5 years post MID-C system implantation
Serious adverse events, and device or procedure-related adverse events
Efficacy endpoint
时间窗: 5 years post MID-C system implantation
Maintenance of major Cobb angle ≤ 30° 5 years post-surgery
次要结局
未报告次要终点