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Neuromuscular DiseasesNCT03863496

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

A study testing Scoliosis surgery in people with Neuromuscular Diseases and Neuromuscular Scoliosis, run by Ilizarov Center at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 25 years
What is being tested?
Scoliosis surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteRussia
Study dates
31 Jan 2018to 14 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • Ilizarov

    Kurgan, 640014

Other trials in Russia

About this study

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.

Read the 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.

Being tested
Scoliosis surgery
Medical subject headings
Neuromuscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scoliosis surgeryProcedure or 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.

Study groups in NCT03863496
Study groupRoleWhat they receive
Neuromuscular scoliosisOtherEfficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
Receives: Procedure: Scoliosis surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First Scoliotic Curve

    First scoliotic curve before surgery in Cobb degrees

    Measured: before surgery

  2. Second Scoliotic Curve

    Second scoliotic curve before surgery in Cobb degrees

    Measured: before surgery

  3. Tilt of the Pelvis Relative to the Horizon

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

    Measured: before surgery

  4. Kyphotic Curve Th5-Th12

    Kyphotic curve Th5-Th12 before surgery in Cobb degrees

    Measured: before surgery

  5. Lordotic Curve L1-S1

    Lordotic curve L1-S1 before surgery in Cobb degrees

    Measured: before surgery

Secondary outcomes (5)
  1. First Scoliosis Curve

    First scoliotic curve after surgery in Cobb degrees

    Measured: 10 days after surgery

  2. Second Scoliotic Curve

    Second scoliotic curve after surgery in Cobb degrees

    Measured: 10 days after surgery

  3. Tilt of the Pelvis Relative to the Horizon

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

    Measured: 10 days after surgery

  4. Kyphotic Curve Th5-Th12

    Kyphotic curve Th5-Th12 after surgery in Cobb degrees

    Measured: 10 days after surgery

  5. Lordotic Curve L1-S1

    Lordotic curve L1-S1 after surgery in Cobb degrees

    Measured: 10 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start31 Jan 2018
  3. Primary completion14 Feb 2021
  4. Study completion14 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03863496
Sponsor's protocol ID
Ilizarov
Status last verified
May 2021
First submitted
6 Feb 2019
Last updated
10 Jun 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Scoliosis surgery in people with Neuromuscular Diseases and Neuromuscular Scoliosis, run by Ilizarov Center at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Scoliotic Curve (time frame: before surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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