NCT03863496

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 6, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

February 6, 2019

Results QC Date

December 5, 2019

Last Update Submit

May 16, 2021

Conditions

Neuromuscular DiseasesNeuromuscular Scoliosis

Outcome Measures

Primary Outcomes (5)

  • First Scoliotic Curve

    First scoliotic curve before surgery in Cobb degrees

    before surgery

  • Second Scoliotic Curve

    Second scoliotic curve before surgery in Cobb degrees

    before surgery

  • Tilt of the Pelvis Relative to the Horizon

    tilt of the pelvis relative to the horizon before surgery in Cobb degrees

    before surgery

  • Kyphotic Curve Th5-Th12

    Kyphotic curve Th5-Th12 before surgery in Cobb degrees

    before surgery

  • Lordotic Curve L1-S1

    Lordotic curve L1-S1 before surgery in Cobb degrees

    before surgery

Secondary Outcomes (5)

  • First Scoliosis Curve

    10 days after surgery

  • Second Scoliotic Curve

    10 days after surgery

  • Tilt of the Pelvis Relative to the Horizon

    10 days after surgery

  • Kyphotic Curve Th5-Th12

    10 days after surgery

  • Lordotic Curve L1-S1

    10 days after surgery

Study Arms (1)

Neuromuscular scoliosis

OTHER

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

Procedure: Scoliosis surgery

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.

Neuromuscular scoliosis

Eligibility Criteria

Age6 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilizarov

Kurgan, 640014, Russia

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Results Point of Contact

Title
Sergey Raybukh
Organization
Ilizarov centre
rso_@mail.ru
+79226716007

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2019

First Posted

March 5, 2019

Study Start

January 31, 2018

Primary Completion

February 14, 2021

Study Completion

February 14, 2021

Last Updated

June 10, 2021

Results First Posted

June 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)