JPRN-UMIN000015904已完成未知
A prospective, multicenter clinical study of the MDT-4113 for the treatment of patients with Severe, Progressive, Life-threatening Early Onset Pediatric Scoliosis:EOS - A prospective, multicenter clinical study of the MDT-4113 for the treatment of patients with Severe, Progressive, Life-threatening Early Onset Pediatric Scoliosis:EOS
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 10
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
- ot applicable 至 10years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Has active infection and/or has significant infectious risk 2. Is diagnosed to allergy or hypersensitivity to metal or is suspect to metal allergy/hypersensitivity 3. General anesthesia is NOT appropriate 4. Operated on spinal fusion with implant(s) 5. Had participated other clinical trial during the last 3 months 6. Has convulsion (If an investigator decides that a patient is not appropriate to enter this study) 7. Has untreated syringomyelia, spinal deformity or spinal cord tumor 8. Reaches skeletal maturity 9. Has inadequate tissue coverage over the operative site 10. Has hypophrenia (If an investigator decides that a patient is not appropriate to enter this study.) 11. Has rib fusion 12. His/her parent or legal guardian has not signed the Informed Consent form
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