Safety and Efficacy Evaluation of Insight GS Growing System

Phase 3Not Yet RecruitingNCT06301984

EVEREST PESQUISA E DESENVOLVIMENTO LTDA26 enrolled

Overview

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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Insight GSDEVICE

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).

Eligibility

Sex: ALLMin age: 3 YearsMax age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * TCLE signed by parents * Ages 3 to 10 years, or Risser 0, or Sanders 1,2,3 and 4 * Cobb angle bigger than 30° * Thoracic spine height T1-T12 less than 22 centimeters * Risk of thoracic insufficiency syndrome (TIS). Exclusion Criteria: * Need for fixation at occipital or cervical levels * Risser sign greater than or equal to 1 * Sanders bigger than 4 * Previous spine surgery * Medullary abnormalities * Existence of malignant processes * Local or systemic inflammations and infections, acute or chronic * Allergy or intolerance to materials * Non-reducible scoliosis * Morbid obesity * Insufficiency or absence of skin coverage

Outcomes

Primary Outcomes

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.