NL-OMON43676已完成不适用
Evaluation of the safety and effectiveness of the MID-C/ApiFix system in adolescent idiopathic scoliosis. - The ApiFix system for the treatment of adolescent idiopathic scoliosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •1. Adolescent idiopathic scoliosis patients (10 years - 17 years old);
- •2. Standing X-ray: 40 to 55 degrees Cobb angle, Lenke type 1 or 5, Risser stage 1-4;
- •3. Lateral bending X-ray: primary curve should be reduced to <35 degrees Cobb angle after lateral bending;
- •4. Subject has good general health;
- •5. Subject and both subject*s guardians/legal representatives are willing to sign a written informed consent form;
- •6. Vertebral rotation <15 degrees (based on Bunnell Scoliometer), and;
- •7. Compliance for exercise therapy (based on verbal confirmation of patient)
排除标准
- •1. Other non-idiopathic form of scoliosis;
- •2. Primary curve Cobb angle >50 degrees;
- •3. Adolescent idiopathic scoliosis which is not defined as Lenke type 1 or 5;
- •4. Previous spine surgery;
- •5. Known allergy to titanium;
- •6. Active systemic disease, such as AIDS, HIV, or active infection;
- •7. Systemic disease that would affect the subject*s welfare or overall outcome of the study, or;
- •8. Mentally compromised.
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