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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular scoliosis | Other | Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scoliosis surgery | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ilizarov | Kurgan | 640014 | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neuromuscular Scoliosis | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients aged 6 to 22 years with neuromuscular scoliosis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | First Scoliotic Curve | First scoliotic curve before surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | before surgery |
|
|
1 year after surgery
implant-dependent complications, Cardiac disorders
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neuromuscular Scoliosis | 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 (NIM Eclipse, Stealth Station S7) and standard anesthetic support. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 12 months after surgery | Cardiac disorders | Non-systematic Assessment | Sudden death syndrome due to cardiomyopathy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergey Raybukh | Ilizarov centre | +79226716007 | rso_@mail.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 25, 2017 | Dec 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| 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 |
| Participants |
| No |
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| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Neuromuscular scoliosis | Count of Participants | Participants |
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| Primary | Second Scoliotic Curve | Second scoliotic curve before surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | before surgery |
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| Primary | Tilt of the Pelvis Relative to the Horizon | tilt of the pelvis relative to the horizon before surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | before surgery |
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| Primary | Kyphotic Curve Th5-Th12 | Kyphotic curve Th5-Th12 before surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | before surgery |
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| Primary | Lordotic Curve L1-S1 | Lordotic curve L1-S1 before surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | before surgery |
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| Secondary | First Scoliosis Curve | First scoliotic curve after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 10 days after surgery |
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| Secondary | Second Scoliotic Curve | Second scoliotic curve after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 10 days after surgery |
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| Secondary | Tilt of the Pelvis Relative to the Horizon | tilt of the pelvis relative to the horizon after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 10 days after surgery |
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| Secondary | Kyphotic Curve Th5-Th12 | Kyphotic curve Th5-Th12 after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 10 days after surgery |
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| Secondary | Lordotic Curve L1-S1 | Lordotic curve L1-S1 after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 10 days after surgery |
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| Post-Hoc | First Scoliotic Curve | First scoliotic curve 12 months after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 12 months after surgery |
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| Post-Hoc | Second Scoliotic Curve | Second scoliotic curve 12 months before surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 12 months after surgery |
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| 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 | Posted | Mean | Standard Deviation | degrees | 12 months after surgery |
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| Post-Hoc | Kyphotic Curve Th5-Th12 | Kyphotic curve Th5-Th12 12 months after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 12 months after surgery |
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| Post-Hoc | Lordotic Curve L1-S1 | Lordotic curve L1-S1 12 months after surgery in Cobb degrees | Posted | Mean | Standard Deviation | degrees | 12 months after surgery |
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| 1 |
| 71 |
| 1 |
| 71 |
| 0 |
| 71 |
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