A prospective, multicenter clinical study of the MDT-4113 for the treatment of patients with Severe, Progressive, Life-threatening Early Onset Pediatric Scoliosis:EOS
- Conditions
- Early Onset Pediatric Scoliosis
- Registration Number
- JPRN-UMIN000015904
- Lead Sponsor
- Medtronic Sofamor Danek, Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method