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临床试验/NCT06075355
NCT06075355尚未招募不适用

Sagittal : Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
116
试验地点
1
主要终点
Evolution of sagittal balance after minimally invasive decompression surgery

研究概览

简要总结

From adulthood onwards, the aging process manifests itself in the spine through loss of disc height and kyphotic deformity. As the general population ages, the prevalence of lumbar degenerative diseases and sagittal imbalance increases. Sagittal balance is a physiological alignment resulting from the effective muscular and ligamentary forces that place patients' heads harmoniously in line with their pelvis. Roussouly first classified this alignment by differentiating four types of balance in an asymptomatic population. He established a link between the varieties of sagittal balance of the spine, the sacral slope and the position of the pelvis in space. He went on to explain sagittal imbalance in the aging population suffering from degenerative diseases.

One of the most common lumbar degenerative diseases is lumbar spinal canal stenosis. Stenosis of the lumbar spinal canal is frequently associated with sagittal imbalance of the spine. Lumbar canal stenosis causes lumbar pain, leg pain, neurogenic intermittent claudication and bladder and rectal disorders. The severity of clinical symptoms increases linearly with progressive sagittal imbalance [8]. We represent the sagittal imbalance of the spine by a positive sagittal vertical axis (SVA) presented by patients to reduce the pressure exerted by the yellow ligament, which is hypertrophied in degenerative disease . Many have shown that this forward-flexing posture can be improved by simple decompression, and that this deformity corresponds to an analgesic position and not to a structural deformity. Little is known about the factors that influence alignment after lumbar canal decompression and short segment fusion.

This study therefore aims to elucidate some of the clinical and radiological factors likely to affect postoperative sagittal balance in patients undergoing simple minimally invasive decompression surgery and short segment fusion (1 or 2 levels).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age ≥ 18 years
  • French-speaking patients
  • Patients undergoing minimally invasive lumbar decompression with or without one- or two-level arthrodesis
  • Patients with preoperative sagittal imbalance measured on EOS images (sagittal vertebral axis > 50 mm)

排除标准

  • Patients under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his or her data for this study
  • Revision surgery

结局指标

主要结局

Evolution of sagittal balance after minimally invasive decompression surgery

时间窗: 3 months

Sagittal Vertebral axis mesurement before and after surgery

次要结局

  • barrey Ratio(3 months)
  • thoracic kyphosis(3 months)
  • sacred gradient(3 months)
  • pelvic incidence(3 months)
  • lumbar lordosis(3 months)
  • pelvic version(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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