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临床试验/NCT03065452
NCT03065452已完成不适用

Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Vertical sagittal axis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Patients who underwent open decompression surgery

Observational study on patients who underwent open decompression surgery

结局指标

主要结局

Vertical sagittal axis

时间窗: 12 months

Evaluation of sagittal parameters

次要结局

  • radiographic evaluation with EOS(12 months)
  • Functional Interest(12 months)
  • Sagittal parameters(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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