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

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 Overview

• Status: Completed
• Conditions: Neuromuscular Diseases; Neuromuscular Scoliosis
• Intervention / Treatment: Procedure: Scoliosis surgery

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 wings. Skeletization of vertebrae will be done within transverse processes. Pedicle support points are set bilaterally cranially at each segment level for the space of 3 segments. Caudal support base is formed with pedicle screws in lateral masses of the sacral bone or iliac crests at the level of L5-S1 vertebrae. Control fluorography is performed in two standard planes in order to control screw position. Two "dynamic" rods are formed on the basis of the distance between screw heads allowing 2 cm for distraction; these are two rods connected with a longitudinal connector and bent following the normal sagittal spine profile. After that, channels are formed on both sides under m. erector spinae in the cranial/caudal direction. Pre-bent rods with connectors are placed into the prepared channels. The metal construct is stabilized with internal set screws. If necessary, the construct may be stiffened with crosslinks. Control fluorography is performed in two standard planes in order to control implant position and evaluate correction. The intervention completes with local dorsal spinal fusion with an autobone at the level of base screws. The wound is sewn up in layers tightly.

Group two: dorsal access to the posterior column is gained in accordance with the preoperative plan. The access length depends on the instrumentation area. Vertebral skeletization is performed within transverse processes. Subgroup 1 - pedicle support points are set bilaterally at each segment level. Subgroup 2 - pedicle support points are set bilaterally in every second segment. Segmented instrumentation of 3 cranial segments to prevent dislocation of metal construct elements at the level of Th2-4 or Th3-5 vertebrae is a special measure. Similar to group I, caudal support base is formed with pedicle screws in lateral masses of the sacral bone or iliac crests at the level of L5-S1 vertebrae. Control fluorography is performed after that in two standard planes in order to control screw position. Segmented facetectomy is recommended for additional spine mobilization. Pre-bent rods are placed into support points. Deformity correction is performed by means of a translational maneuver, segmented distraction (concave side) and compression (convex side). The metal construct is stabilized with internal set screws. If necessary, the construct may be stiffened with crosslinks. Control fluorography is performed in two standard planes in order to control implant position and evaluate correction. The intervention completes with dorsal spinal fusion with an autobone along the implants. The postoperative bed is subjected to Redon drain. The drainage is exteriorized to the skin via a separate puncture. The wound is sewn up in layers tightly.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Kurgan, Russian Federation, 640014
    • Ilizarov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Neuromuscular scoliosis; Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity	Procedure: Scoliosis surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Scoliosis Curve	First scoliotic curve after surgery in Cobb degrees	10 days after surgery
Second Scoliotic Curve	Second scoliotic curve after surgery in Cobb degrees	10 days after surgery
Tilt of the Pelvis Relative to the Horizon	tilt of the pelvis relative to the horizon after surgery in Cobb degrees	10 days after surgery
Kyphotic Curve Th5-Th12	Kyphotic curve Th5-Th12 after surgery in Cobb degrees	10 days after surgery
Lordotic Curve L1-S1	Lordotic curve L1-S1 after surgery in Cobb degrees	10 days after surgery

Collaborators and Investigators

• Sponsor: Ilizarov Center
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2018
• Primary Completion (ACTUAL): February 14, 2021
• Study Completion (ACTUAL): February 14, 2021

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: May 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Neuromuscular Diseases
• Other Study ID Numbers: Ilizarov

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No