Status:
COMPLETED
Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
Lead Sponsor:
Ilizarov Center
Collaborating Sponsors:
Medtronic
Conditions:
Neuromuscular Diseases
Neuromuscular Scoliosis
Eligibility:
All Genders
6-25 years
Phase:
NA
Brief Summary
This study was sponsored by Federal state budgetary institution "Russian scientific center for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of Russian Federation. ...
Detailed Description
First group of patients: local dorsal access. Cranial access: at the level of posterior Th2 5 structures and caudally at the level of L4-S2 vertebrae with exposure of posterior upper spines of iliac w...
Eligibility Criteria
Inclusion
- Signed and dated informed consent for participation in the study (separate informed consents for child and parents/caregivers), obtained before conducting any study procedures
- Verified and documented diagnosis (neuromuscular desease, NMD) with the results of neurologic examination
- Deformity of thoracic and/or lumbar spine associated with NMD, which requires surgical intervention
Exclusion
- Patient unwillingness or inability to follow study procedures
- Absence of signed and dated informed consent for participation in the study (as for child and for parents/caregivers)
- Patient participation in another clinical study, which can influence the results of this study
- Life expectancy \<12 months
- Concomitant diseases, which preclude patient participation in this study according to doctor's opinion
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2021
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03863496
Start Date
January 31 2018
End Date
February 14 2021
Last Update
June 10 2021
Active Locations (1)
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1
Ilizarov
Kurgan, Russia, 640014