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临床试验/NCT01760434
NCT01760434已完成不适用

Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2013年1月最近更新:
适应症
干预措施

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

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

Other

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Noelle Larson

Co-Principal Investigator

Mayo Clinic

研究点 (2)

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