Trial Outcomes & Findings for Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity (NCT NCT03863496)

NCT ID: NCT03863496

Last Updated: 2021-06-10

Results Overview

First scoliotic curve before surgery in Cobb degrees

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 71 participants
• Primary outcome timeframe: before surgery
• Results posted on: 2021-06-10

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Neuromuscular Scoliosis n=71 Participants 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.
Age, Categorical <=18 years	65 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	14 years STANDARD_DEVIATION 3.605 • n=93 Participants
Sex: Female, Male Female	26 Participants n=93 Participants
Sex: Female, Male Male	45 Participants n=93 Participants
Race/Ethnicity, Customized Russia	71 participants n=93 Participants
Region of Enrollment Russia	71 Participants n=93 Participants
Neuromuscular scoliosis	71 Participants n=93 Participants

PRIMARY outcome

Timeframe: before surgery

First scoliotic curve before surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=69 Participants 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.
First Scoliotic Curve	71.4029 degrees Standard Deviation 27.60483

PRIMARY outcome

Timeframe: before surgery

Second scoliotic curve before surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=16 Participants 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.
Second Scoliotic Curve	44,7125 degrees Standard Deviation 23,14289

PRIMARY outcome

Timeframe: before surgery

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

Outcome measures

Measure	Neuromuscular Scoliosis n=70 Participants 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.
Tilt of the Pelvis Relative to the Horizon	14.7729 degrees Standard Deviation 10.19554

PRIMARY outcome

Timeframe: before surgery

Kyphotic curve Th5-Th12 before surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=70 Participants 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.
Kyphotic Curve Th5-Th12	28,7029 degrees Standard Deviation 24,33570

PRIMARY outcome

Timeframe: before surgery

Lordotic curve L1-S1 before surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=70 Participants 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.
Lordotic Curve L1-S1	53,8829 degrees Standard Deviation 37,75711

SECONDARY outcome

Timeframe: 10 days after surgery

First scoliotic curve after surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=69 Participants 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.
First Scoliosis Curve	31.4667 degrees Standard Deviation 19.21541

SECONDARY outcome

Timeframe: 10 days after surgery

Second scoliotic curve after surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=15 Participants 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.
Second Scoliotic Curve	28,5533 degrees Standard Deviation 15,52168

SECONDARY outcome

Timeframe: 10 days after surgery

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

Outcome measures

Measure	Neuromuscular Scoliosis n=70 Participants 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.
Tilt of the Pelvis Relative to the Horizon	6.1514 degrees Standard Deviation 5.85862

SECONDARY outcome

Timeframe: 10 days after surgery

Kyphotic curve Th5-Th12 after surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=70 Participants 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.
Kyphotic Curve Th5-Th12	21,7486 degrees Standard Deviation 14,12344

SECONDARY outcome

Timeframe: 10 days after surgery

Lordotic curve L1-S1 after surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=70 Participants 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.
Lordotic Curve L1-S1	49,6700 degrees Standard Deviation 19,06499

POST_HOC outcome

Timeframe: 12 months after surgery

First scoliotic curve 12 months after surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=44 Participants 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.
First Scoliotic Curve	31,6614 degrees Standard Deviation 19,25580

POST_HOC outcome

Timeframe: 12 months after surgery

Second scoliotic curve 12 months before surgery in Cobb degrees

Outcome measures

Measure	Neuromuscular Scoliosis n=8 Participants 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.
Second Scoliotic Curve	28,5750 degrees Standard Deviation 23,24065

POST_HOC outcome

Timeframe: 12 months after surgery

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

Outcome measures

Measure	Neuromuscular Scoliosis n=39 Participants 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.
Tilt of the Pelvis Relative to the Horizon	7,0513 degrees Standard Deviation 6,40924

POST_HOC outcome

Timeframe: 12 months after surgery

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

Outcome measures

Measure	Neuromuscular Scoliosis n=43 Participants 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.
Kyphotic Curve Th5-Th12	22,9581 degrees Standard Deviation 15,93596

POST_HOC outcome

Timeframe: 12 months after surgery

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

Outcome measures

Measure	Neuromuscular Scoliosis n=42 Participants 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.
Lordotic Curve L1-S1	51.7405 degrees Standard Deviation 15.08844

Adverse Events

Neuromuscular Scoliosis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Neuromuscular Scoliosis n=71 participants at risk 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.
Cardiac disorders 12 months after surgery	1.4% 1/71 • Number of events 1 • 1 year after surgery implant-dependent complications, Cardiac disorders

Other adverse events

Adverse event data not reported

Additional Information

Sergey Raybukh

Ilizarov centre

Phone: +79226716007

Email: rso_@mail.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place