Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Number of re-operations
研究概览
简要总结
The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws
Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group
详细描述
The purpose of this clinical study is to show that the growth guiding construct with DePuy Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 - 10 years
- •Diagnosis of Early Onset Scoliosis with any of the following etiologies:
- •Idiopathic Congenital Neuromuscular Syndromic Mesenchymal
- •Significant growth potential defined by any of the following: pre peek growth velocity bone age < 10; open triradiate cartilage
- •An expected significant spinal deformity of more than 80 degrees at skeletal maturity
- •Signed informed consent as legally required (patient, parents, etc.)
- •Willingness and ability of the patient to participate in the clinical investigation including imaging and FU procedures
- •Willingness and ability of the parents to support the patient in his/her study participation
- •Ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation
- •Signed informed consent by patient / parent(s)
排除标准
- •Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees
- •Prior spinal surgery
- •Skeletal maturity
- •Any not medically managed severe systemic disease
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Number of re-operations
时间窗: 3 years FU
Number of re-operations of the spine per patient in both groups after 3 years of FU
次要结局
- Pulmonary function:(10 years)
- Standing height(10 years)
- Adverse Events related to the procedure and/or device under investigation(10 years)
- Quality of life(10 years)
- Growth potential(10 years)
- Sitting height(10 years)
- Radiographic measurements(10 years)
- Curve / deformity type characteristics(10 years)