N/A
N=71
Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
Neuromuscular Diseases · Neuromuscular Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT03863496 ↗Enrolled (actual)
71
Serious AEs
1.4%
Results posted
Jun 2021
Primary outcome: Primary: First Scoliotic Curve — 71.4029 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Scoliosis surgery (Procedure)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Ilizarov Center
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First Scoliotic Curve |
31,6614 | — |
| PRIMARY Second Scoliotic Curve |
28,5750 | — |
| PRIMARY Tilt of the Pelvis Relative to the Horizon |
7,0513 | — |
| PRIMARY Kyphotic Curve Th5-Th12 |
22,9581 | — |
| PRIMARY Lordotic Curve L1-S1 |
51.7405 | — |
| SECONDARY First Scoliosis Curve |
31.4667 | — |
| SECONDARY Second Scoliotic Curve |
28,5750 | — |
| SECONDARY Tilt of the Pelvis Relative to the Horizon |
7,0513 | — |
| SECONDARY Kyphotic Curve Th5-Th12 |
22,9581 | — |
| SECONDARY Lordotic Curve L1-S1 |
51.7405 | — |
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. The study will take place at this center.
It is expected to enroll 70 patients aged 6-25 years with NMD, all of whom will be subjected to thoracic and lumbar spinal deformity surgery.
Patients will be divided into two groups depending on skeletal maturity. The degree of skeletal maturity will be determined on the basis of an X-ray study of spinal and pelvic bones. The type of surgical correction will depend on the group.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03863496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.