Neuromuscular Diseases Clinical Trial
Official title:
Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
Verified date | May 2021 |
Source | Ilizarov Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | February 14, 2021 |
Est. primary completion date | February 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 25 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Ilizarov | Kurgan |
Lead Sponsor | Collaborator |
---|---|
Ilizarov Center | Medtronic |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First Scoliotic Curve | First scoliotic curve before surgery in Cobb degrees | before surgery | |
Primary | Second Scoliotic Curve | Second scoliotic curve before surgery in Cobb degrees | before surgery | |
Primary | Tilt of the Pelvis Relative to the Horizon | tilt of the pelvis relative to the horizon before surgery in Cobb degrees | before surgery | |
Primary | Kyphotic Curve Th5-Th12 | Kyphotic curve Th5-Th12 before surgery in Cobb degrees | before surgery | |
Primary | Lordotic Curve L1-S1 | Lordotic curve L1-S1 before surgery in Cobb degrees | before surgery | |
Secondary | First Scoliosis Curve | First scoliotic curve after surgery in Cobb degrees | 10 days after surgery | |
Secondary | Second Scoliotic Curve | Second scoliotic curve after surgery in Cobb degrees | 10 days after surgery | |
Secondary | 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 | |
Secondary | Kyphotic Curve Th5-Th12 | Kyphotic curve Th5-Th12 after surgery in Cobb degrees | 10 days after surgery | |
Secondary | Lordotic Curve L1-S1 | Lordotic curve L1-S1 after surgery in Cobb degrees | 10 days after surgery |
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