CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 71 enrolled
Drug / intervention
Scoliosis surgeryprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03863496
NCT03863496N/ACompleted

Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity

Ilizarov Center·interventional·Posted Mar 5, 2019·Updated Jun 10, 2021

In Brief

A clinical study evaluating Scoliosis surgery for Neuromuscular Diseases and Neuromuscular Scoliosis. Completed, enrolled 71 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 5, 2019
Enrollment StartJan 31, 2018
Primary CompletionFeb 14, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.3 years ago

Interventions

Scoliosis surgeryprocedure

All patients will be implanted Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control and standard anesthetic support.