NCT06950853招募中不适用
ESCAPE : Evaluation of Spinal Conservation by Endoscopic Procedures to Avoid Fusion
University Hospital, Bordeaux10 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 375
- 试验地点
- 10
- 主要终点
- Surgical reintervention
研究概览
简要总结
The recent development and expansion of endoscopic surgery has made it possible to offer an alternative to this therapeutic escalation. This method allows decompression procedures to be performed using optimized and minimally destructive surgical approaches, which contributes to preserving the physiological function of the lumbar spine and in particular its stability.
The main hypothesis of the research is that the use of endoscopic techniques for decompression of the lumbar spine allows a reduction in the indication for lumbar arthrodesis.
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
- •Patient ≥ 18 years old
- •Patient consulting for a medical reason involving a spinal pathology in the investigating center :
- •Syndrome adjacent to an old lumbar arthrodesis defined on preoperative radiographs by an antero-posterior translation > 3 mm, segmental kyphosis > 10° or a disc height reduced by more than 50%, or on preoperative MRI by central stenosis of grade C or D of the Schizas classification or a herniated disc Grade 1 or 2 degenerative spondylolisthesis, i.e. with slippage less than 50% of the depth of the underlying vertebral body.
- •Lumbar stenosis complicating lumbar scoliosis defined by a deformation with rotation of the vertebral bodies on a frontal radiograph (absence of centering of the spinous process between the two pedicles of the vertebra concerned) and a Cobb angle greater than 20° or a rotational dislocation .
- •Indication for spinal surgery by endoscopy
排除标准
- •Patient under guardianship or curatorship,
- •Persons deprived of liberty by judicial or administrative decision,
- •Persons undergoing psychiatric treatment under duress requiring the consent of the legal representative
- •Persons unable to express their consent,
- •Persons under legal protection,
- •Patient not affiliated to a social protection scheme.
结局指标
主要结局
Surgical reintervention
时间窗: one year
rate of surgical reinterventions within the year for arthrodesis of the operated segment.
次要结局
未报告次要终点
研究者
研究点 (10)
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