Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03863496
Enrollment
71
Registered
2019-03-05
Start date
2018-01-31
Completion date
2021-02-14
Last updated
2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Diseases, Neuromuscular Scoliosis

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.

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.

Interventions

PROCEDUREScoliosis 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.

Sponsors

Medtronic
CollaboratorINDUSTRY
Ilizarov Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lordotic Curve L1-S1before surgeryLordotic curve L1-S1 before surgery in Cobb degrees
Kyphotic Curve Th5-Th12before surgeryKyphotic curve Th5-Th12 before surgery in Cobb degrees
First Scoliotic Curvebefore surgeryFirst scoliotic curve before surgery in Cobb degrees
Second Scoliotic Curvebefore surgerySecond scoliotic curve before surgery in Cobb degrees
Tilt of the Pelvis Relative to the Horizonbefore surgerytilt of the pelvis relative to the horizon before surgery in Cobb degrees

Secondary

MeasureTime frameDescription
First Scoliosis Curve10 days after surgeryFirst scoliotic curve after surgery in Cobb degrees
Second Scoliotic Curve10 days after surgerySecond scoliotic curve after surgery in Cobb degrees
Tilt of the Pelvis Relative to the Horizon10 days after surgerytilt of the pelvis relative to the horizon after surgery in Cobb degrees
Kyphotic Curve Th5-Th1210 days after surgeryKyphotic curve Th5-Th12 after surgery in Cobb degrees
Lordotic Curve L1-S110 days after surgeryLordotic curve L1-S1 after surgery in Cobb degrees

Countries

Russia

Participant flow

Participants by arm

ArmCount
Neuromuscular Scoliosis
Scoliosis surgery: All patients will be implanted with telescopic connector Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control (NIM Eclipse, Stealth Station S7) and standard anesthetic support.
71
Total71

Baseline characteristics

CharacteristicNeuromuscular Scoliosis
Age, Categorical
<=18 years
65 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous14 years
STANDARD_DEVIATION 3.605
Neuromuscular scoliosis71 Participants
Race/Ethnicity, Customized
Russia
71 participants
Region of Enrollment
Russia
71 Participants
Sex: Female, Male
Female
26 Participants
Sex: Female, Male
Male
45 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 71
other
Total, other adverse events
0 / 71
serious
Total, serious adverse events
1 / 71

Outcome results

Primary

First Scoliotic Curve

First scoliotic curve before surgery in Cobb degrees

Time frame: before surgery

ArmMeasureValue (MEAN)Dispersion
Neuromuscular ScoliosisFirst Scoliotic Curve71.4029 degreesStandard Deviation 27.60483
Primary

Kyphotic Curve Th5-Th12

Kyphotic curve Th5-Th12 before surgery in Cobb degrees

Time frame: before surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisKyphotic Curve Th5-Th1228,7029 degrees
Primary

Lordotic Curve L1-S1

Lordotic curve L1-S1 before surgery in Cobb degrees

Time frame: before surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisLordotic Curve L1-S153,8829 degrees
Primary

Second Scoliotic Curve

Second scoliotic curve before surgery in Cobb degrees

Time frame: before surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisSecond Scoliotic Curve44,7125 degrees
Primary

Tilt of the Pelvis Relative to the Horizon

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

Time frame: before surgery

ArmMeasureValue (MEAN)Dispersion
Neuromuscular ScoliosisTilt of the Pelvis Relative to the Horizon14.7729 degreesStandard Deviation 10.19554
Secondary

First Scoliosis Curve

First scoliotic curve after surgery in Cobb degrees

Time frame: 10 days after surgery

ArmMeasureValue (MEAN)Dispersion
Neuromuscular ScoliosisFirst Scoliosis Curve31.4667 degreesStandard Deviation 19.21541
Secondary

Kyphotic Curve Th5-Th12

Kyphotic curve Th5-Th12 after surgery in Cobb degrees

Time frame: 10 days after surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisKyphotic Curve Th5-Th1221,7486 degrees
Secondary

Lordotic Curve L1-S1

Lordotic curve L1-S1 after surgery in Cobb degrees

Time frame: 10 days after surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisLordotic Curve L1-S149,6700 degrees
Secondary

Second Scoliotic Curve

Second scoliotic curve after surgery in Cobb degrees

Time frame: 10 days after surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisSecond Scoliotic Curve28,5533 degrees
Secondary

Tilt of the Pelvis Relative to the Horizon

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

Time frame: 10 days after surgery

ArmMeasureValue (MEAN)Dispersion
Neuromuscular ScoliosisTilt of the Pelvis Relative to the Horizon6.1514 degreesStandard Deviation 5.85862
Post Hoc

First Scoliotic Curve

First scoliotic curve 12 months after surgery in Cobb degrees

Time frame: 12 months after surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisFirst Scoliotic Curve31,6614 degrees
Post Hoc

Kyphotic Curve Th5-Th12

Kyphotic curve Th5-Th12 12 months after surgery in Cobb degrees

Time frame: 12 months after surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisKyphotic Curve Th5-Th1222,9581 degrees
Post Hoc

Lordotic Curve L1-S1

Lordotic curve L1-S1 12 months after surgery in Cobb degrees

Time frame: 12 months after surgery

ArmMeasureValue (MEAN)Dispersion
Neuromuscular ScoliosisLordotic Curve L1-S151.7405 degreesStandard Deviation 15.08844
Post Hoc

Second Scoliotic Curve

Second scoliotic curve 12 months before surgery in Cobb degrees

Time frame: 12 months after surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisSecond Scoliotic Curve28,5750 degrees
Post Hoc

Tilt of the Pelvis Relative to the Horizon

tilt of the pelvis relative to the horizon 12 months after surgery in Cobb degrees

Time frame: 12 months after surgery

ArmMeasureValue (MEAN)
Neuromuscular ScoliosisTilt of the Pelvis Relative to the Horizon7,0513 degrees

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026