Early Onset Pediatric Scoliosis
Conditions
Interventions
Implantation of MDT-4113 From operation for MDT-4113 implantation to postoperative 24 months or final fusion operation
Sponsors
Medtronic Sofamor Danek, Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed to severe, progressive, life-threatening Early Onset Scoliosis including congenital scoliosis, juvenile scoliosis, neuromuscular scoliosis and syndromic scoliosis 2. Preoperative major curve Cobb Angle >50 +/-5 degrees (+/-5 degrees is error of measurement) 3. Spinal Curve length over at least 6 segments of the spine 4. Is less than 10 years of age at the time of the index surgery 5. His/her parent or legal guardian has signed the Informed Consent form
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success is defined as a postoperative 24 months major curve Cobb angle less than or equal to 50+/-5 degrees or an improvement of at least 50% compared to preoperative. (+/-5 is error of measurement) | — |
Countries
Japan
Contacts
Public ContactAsami Taguchi
Medtronic Sofamor Danek, Co., Ltd. Regulatory and Clinical Affairs
Outcome results
None listed