The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,602
- 试验地点
- 27
- 主要终点
- Clinical and Radiographic
研究概览
简要总结
The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.
详细描述
This multi-center study will evaluate the long-term clinical and radiographic outcomes of Early Onset Scoliosis (EOS) and other Early Onset Spinal and Chest Wall Deformities in a large population of patients.
The study will attempt to answer the following clinical questions:
-
How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:
-
Age groups
-
Etiologic groups
-
Treatment types including operative and non-operative methods
-
Patients who receive definitive spinal fusion versus those who do not
-
How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:
-
Age groups
-
Etiologic groups
-
Treatment types including operative and non-operative methods
-
Patients who receive definitive spinal fusion versus those who do not
-
How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any age and any diagnosis who undergo a growth-friendly surgical procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid constructs, spinal tethering and staples
- •Patients of any age and any diagnosis who undergo casting
- •Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the thoracic and/or lumbar spine
- •Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic and/or lumbar spine measuring > 25 degrees. Observed and braced patients included
排除标准
- •Cervical spine anomalies alone will not be included
- •Patient/family is unwilling to participate in the study
结局指标
主要结局
Clinical and Radiographic
时间窗: 18 years
Evaluation of long-term clinical measures such as: BMI, Pulmonary functionality, incidence of complications; and radiographic outcomes (e.g. coronal spinal curvature, sagittal profile, spinal and thoracic growth, coronal and sagittal alignment.
次要结局
- Patient based outcomes(18 years)