Safety and Efficacy Evaluation of Insight GS Growing System in the Surgical Treatment of Early Onset Scoliosis (EOS)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Coronal Cobb angle change 24 months after installation of the Insight GS system.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Experimental
In the initial assessment, data regarding the general health status will be collected and imaging exams (panoramic X-ray of the anteroposterior, lateral and traction spine, and X-ray of the right and left hands) and laboratory tests (blood count, coagulogram, dosage of sodium and potassium, urea and creatinine levels, AST and ALT, PCR, ESR, type I urine and urine culture) will be requested. During the preoperative consultation, measurements of the study variables will be obtained from the imaging exams), in addition to obtaining photographs of the patients. To install the Insight GS system, the surgical approach will be carried out according to the manufacturer's instructions for use, briefly described below. A posterior midline skin incision is made from the upper to the lower instrumented level. Subfascial exposure of the spine is performed, ensuring that the facet joint capsules are spared. Pedicle screws are inserted bilaterally at the cranial and caudal ends of the instrumentati
干预措施: Insight GS (Device)
结局指标
主要结局
Coronal Cobb angle change 24 months after installation of the Insight GS system.
时间窗: 24 months after Insight GS System placement
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.
次要结局
- Number of Adverse event ocurrence assessed by clinical evaluation(24 months after Insight GS System placement)
- Patients' pain assessed by Wong-Baker non-verbal facial scale(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(24 months after Insight GS System placement)
- Patient's satisfaction assessed by EOSQ-24 scale(24 months after Insight GS System placement)