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.
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
- Conditions the study is for
- Neuromuscular Diseases, Neuromuscular Scoliosis
- 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.
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.
- Conditions
- Neuromuscular Diseases, Neuromuscular Scoliosis
- 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 group | Role | What they receive |
|---|---|---|
| Neuromuscular scoliosis | Other | Efficacy 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.
First Scoliotic Curve
First scoliotic curve before surgery in Cobb degrees
Measured: before surgery
Second Scoliotic Curve
Second scoliotic curve before surgery in Cobb degrees
Measured: before surgery
Tilt of the Pelvis Relative to the Horizon
tilt of the pelvis relative to the horizon before surgery in Cobb degrees
Measured: before surgery
Kyphotic Curve Th5-Th12
Kyphotic curve Th5-Th12 before surgery in Cobb degrees
Measured: before surgery
Lordotic Curve L1-S1
Lordotic curve L1-S1 before surgery in Cobb degrees
Measured: before surgery
Secondary outcomes (5)
First Scoliosis Curve
First scoliotic curve after surgery in Cobb degrees
Measured: 10 days after surgery
Second Scoliotic Curve
Second scoliotic curve after surgery in Cobb degrees
Measured: 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
Measured: 10 days after surgery
Kyphotic Curve Th5-Th12
Kyphotic curve Th5-Th12 after surgery in Cobb degrees
Measured: 10 days after surgery
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.
- First posted5 Mar 2019
- Study start31 Jan 2018
- Primary completion14 Feb 2021
- Study completion14 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ilizarov Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
- ClinicalTrials.gov ID
- NCT03863496
- Acronym / sponsor ID
- Ilizarov
- Conditions
- Neuromuscular Diseases, Neuromuscular Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ilizarov CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 14 Feb 2021 (actual)
- Study completion
- 14 Feb 2021 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Posted 10 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular scoliosis | Other | Procedure: Scoliosis surgeryEfficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scoliosis surgeryAll 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. | Procedure or surgery | Neuromuscular scoliosis |
Primary outcome
First Scoliotic Curve
Time frame: before surgery
First scoliotic curve before surgery in Cobb degrees
Second Scoliotic Curve
Time frame: before surgery
Second scoliotic curve before surgery in Cobb degrees
Tilt of the Pelvis Relative to the Horizon
Time frame: before surgery
tilt of the pelvis relative to the horizon before surgery in Cobb degrees
Kyphotic Curve Th5-Th12
Time frame: before surgery
Kyphotic curve Th5-Th12 before surgery in Cobb degrees
Lordotic Curve L1-S1
Time frame: before surgery
Lordotic curve L1-S1 before surgery in Cobb degrees
5 secondary outcomes
First Scoliosis Curve
Time frame: 10 days after surgery
Second Scoliotic Curve
Time frame: 10 days after surgery
Tilt of the Pelvis Relative to the Horizon
Time frame: 10 days after surgery
Kyphotic Curve Th5-Th12
Time frame: 10 days after surgery
Lordotic Curve L1-S1
Time frame: 10 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.