Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant (CLE/EOS)
Lumbar stenosis (LSS) is the most frequent degenerative lumbar disease and is the most frequent indication for spinal surgery. When non-invasive treatments fail, decompression surgery is the gold standard therapy for the majority of patients and generally improves symptoms.
However, few studies have investigated the improvement in posture (radiological parameters) after surgery. In lumbar stenosis, patients may present a forward leaning posture (to relieve pain), which is responsible for sagittal imbalance.
The aim of this prospective study was to evaluate the repercussions of decompression surgery on sagittal balance and to compare these with aux clinical results. investigators included patients operated on for isolated lumbar canal stenosis.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Dijon、法国、21079
- CHU de Dijon
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Symptoms and signs of neurogenic claudication and radiological signs of central lumbar stenosis;
- Patients undergoing open decompression surgery ≤ 3 levels,
- All patients with symptoms that did not respond to at least 3 months of non-invasive treatment.
Exclusion Criteria:
Patients were excluded from the study if they had one or several of the following clinical and/or radiological criteria:
- spondylolisthesis (disc slip > 5 mm),
- criteria showing instability (variation of > 10° in the angle formed by the vertebral endplates on dynamic images).
- scoliosis (Cobb angle > 20 °).
- Patients lost to follow-up were excluded.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
|---|
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Patients who underwent open decompression surgery
Observational study on patients who underwent open decompression surgery
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vertical sagittal axis
大体时间：12 months
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Evaluation of sagittal parameters
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
radiographic evaluation with EOS
大体时间：12 months
|
Use of the EOS system and 3D SterEOS software o carry out very precise measurements and 3D reconstructions by bone modeling which give access to new parameters
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12 months
|
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Functional Interest
大体时间：12 months
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Stenosis self-questionnaire (Zurich Claudication Questionnaire)
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12 months
|
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Sagittal parameters
大体时间：12 months
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PI (pelvic incidence) in degrees,
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12 months
|
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Sagittal parameters
大体时间：12 months
|
SS (sacral slope) in degrees
|
12 months
|
|
Sagittal parameters
大体时间：12 months
|
PT (pelvic tilt) in degrees
|
12 months
|
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Sagittal parameters
大体时间：12 months
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LL (lumbar lordosis) in degrees
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12 months
|
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Sagittal parameters
大体时间：12 months
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TK in degrees
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12 months
|
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Sagittal parameters
大体时间：12 months
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TPA (T1 Pelvic Angle) in degrees
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12 months
|
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Sagittal parameters
大体时间：12 months
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C7 Barrey's ratio as a percentage
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12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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