Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Cobb angle and sagittal plane alignment
研究概览
简要总结
Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.
详细描述
The investigators hypothesize that sagittal alignment and thoracic volumes will predict successful treatment outcomes as measured by improved pulmonary function and health-related quality of life in adolescent idiopathic scoliosis patients at a minimum 20-year follow-up. Significant focus has been placed on the coronal plane in order to determine treatment indications for scoliosis, but with new understanding about the important of sagittal balance and pulmonary function, the treatment indications should be broadened. Thus, the investigators propose the following study to explore parameters associated with a durable and acceptable outcome following scoliosis treatment, minimizing the need for further surgery and to optimizing quality of life and pulmonary health. Beyond the standard radiographs and Scoliosis Research Society (SRS) scores, this study undertakes a comprehensive assessment of health-related quality of life, chest asymmetry and body satisfaction scoring, sagittal plane parameters, and 3D modeling of the childhood and current spinothoracic deformity. Thus, the investigators research team is uniquely poised to determine broader treatment indications for scoliosis. The overarching goal of this research effort is to determine new parameters based on thoracic volume and sagittal plane alignment in addition to coronal deformity in order to determine the appropriate treatment threshold for surgical intervention in children with adolescent idiopathic scoliosis.
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
- 30 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adolescent idiopathic scoliosis made before age 18
- •Diagnosis of adolescent idiopathic scoliosis prior to 1994
- •Treatment with bracing, observation, or surgery prior to age 18 and 1994
- •Adequate radiographs/medical records available from time of diagnosis
排除标准
- •Neuromuscular scoliosis
- •Inadequate radiographs/medical records available from time of diagnosis
研究组 & 干预措施
Long-Term Outcomes
Patients will be recruited who were diagnosed with adolescent idiopathic scoliosis prior to age 18 and before 1994 (minimum 20 year outcomes) with available xrays. Patients will be included who were treated with surgery, observation, or bracing. Patients will return for a one-time visit for new xrays, physical exam, health-related quality of life surveys, and pulmonary function testing.
干预措施: Long-term outcomes (Other)
结局指标
主要结局
Cobb angle and sagittal plane alignment
时间窗: 20 years
Cobb angle and sagittal plane alignment at minimum 20 year follow-up after bracing, surgery or observation for adolescent idiopathic scoliosis
Scoliosis curve magnitude
时间窗: Nov. 2014
次要结局
- Health-related quality of life(Nov. 2014)
- Pulmonary function testing(20 years)
研究者
A. Noelle Larson
Co-Principal Investigator
Mayo Clinic
