Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Long-term quality of life
研究概览
简要总结
Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity.
Posterior arthrodesis correction is a common practice surgery for the treatment of AIS after failure of medical treatment with a corset or functional rehabilitation. Surgery allows functional improvement and is indicated for curves greater than medically treated scoliosis.
The objective of this international study is to have a better understanding of the long-term outcomes (> 20 years of follow-up) after treatment (surgical and non-surgical) of AIS and to compare the long-term status of the patient with AIS to the general population of the same age, sex and comorbidities.
All of this information will help justify or modify the strategy, techniques and goals of early treatment in adolescence to achieve a better long-term outcome.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Adolescent Idiopathic Scoliosis
- •Main baseline curve magnitude over 40º
- •Aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
- •More than 20 years of follow up
- •Current contact information available
排除标准
- •Non-idiopathic scoliosis
- •Younger than 10 or older than 18 at the time of initial treatment
- •Less than 20 years of follow up
- •Patients unable to understand and answer the questionnaires because of language difficulties or because of cognitive impairments
结局指标
主要结局
Long-term quality of life
时间窗: 1 day
Evaluate from the specific questionnaire for vertebral deformities: Scoliosis Research Society revisited(SRS-22r) (scale 0-5) with 5 sub-domains,higher scores representing greater patient quality of life.
次要结局
- The long-term quality of life(1 day)