Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 3
- 主要终点
- Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward.
研究概览
简要总结
The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis.
详细描述
The motion behavior in the unfused segments of the spine following instrumentation is poorly understood and the implications of hyper or hypo-mobility have not been clearly defined. The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the following specific clinical questions:
-
Further elucidate the motion behavior of the distal unfused spinal segments, specifically:
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Does motion differ at various post-operative time points (2 year post-op patients versus 5 or 10 year post-op patients)?
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Can predictive factors be identified with post-operative altered motion?
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Further elucidate the relationship of the motion in the unfused spinal segments to the lowest instrumented vertebrae.
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Determine the relationship of the total length of fusion to the motion in the unfused spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6 patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).
-
Determine the relationship between clinical examinations (i.e. reports of pain or functional limitations) and patient reported outcomes (Health Related Quality of Life Outcome Tools) to motion in the distal unfused segments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to the primary and co-investigator's facilities will be offered inclusion into the study if they meet the following inclusion criteria:
- •Patient age < 21 years
- •Male or female
- •Diagnosis of Adolescent Idiopathic Scoliosis
- •Any Lenke Classification type
- •Underwent surgical correction of the spinal deformity with a fusion
- •Are due for their 10 year post-operative visit
排除标准
- •Patients will be excluded from study inclusion if they meet the following exclusion criteria:
- •Neuromuscular co-morbidity
结局指标
主要结局
Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward.
时间窗: 10 years
Data collected at patients 10 years visit.
次要结局
未报告次要终点