Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE). Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study. Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).
Hospital Ortopédico AACD
São Paulo, São Paulo, Brazil
Coronal Cobb angle change 24 months after installation of the Insight GS system.
To determine the Cobb angle, a line will be used on the upper edge of the most inclined upper vertebra and on the lower edge of the most inclined lower vertebra, then the lines will be crossed and the measurement of the angle where they cross is the angle of Cobb. The measurement will be performed manually using conventional radiography and measuring the angle using the Cobb ruler.
Time frame: 24 months after Insight GS System placement
Number of Adverse event ocurrence assessed by clinical evaluation
Adverse event monitoring
Time frame: 24 months after Insight GS System placement
Changes in patient's trunk height assessed by T1 to T12 distance and the T1 to S1 distance on full-spine radiographs
Spinal length will be assessed by measuring the T1 to T12 distance and the T1 to S1 distance on full-spine radiographs. The distance from T1 to T12 was measured as the length of a straight line joining the middle portion of the T1 vertebral end plate and the lower T12 vertebral end plate. Likewise, the distance T1 to S1 will be measured as the length of a direct line joining the middle portion of the upper end vertebral plate of T1 and the upper portion of the S1 vertebral end plate (8). The measurement will be carried out by a single operator, using conventional radiography and an analog ruler measured in centimeters.
Time frame: 24 months after Insight GS System placement
Patients' pain assessed by Wong-Baker non-verbal facial scale
To measure patients' pain, the Wong-Baker non-verbal facial scale will be used
Time frame: 24 months after Insight GS System placement
Patient's satisfaction assessed by EOSQ-24 scale
To assess the impact and satisfaction of treatment on caregivers or guardians, the Portuguese version of the 24-Item Early-Onset Scoliosis Questionnaire (EOSQ-24) scale will be used (10).
Time frame: 24 months after Insight GS System placement
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