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临床试验/NCT06904326
NCT06904326招募中不适用

Assessment of Spinal Stability by Dynamic Radiography After Unilateral Biportal Endoscopic Lumbar Decompression Surgery

Clinique Saint Jean, France1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年5月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Spinal stability rate

研究概览

简要总结

Degenerative pathologies of the spine affect a large proportion of the increasingly ageing population, and are a major public health issue. When conservative treatments (physiotherapy, analgesics, infiltrations) fail, surgical treatment is preferred.

Traditionally, a simple lumbar recalibration operation is preferred (bilateral laminectomy decompression), but this may affect spinal stability. In cases of spondylolisthesis or preoperative instability, lumbar fusion (arthrodesis) is sometimes necessary to avoid the risk of major instability, but such an operation is not without risk and may require repeat surgery.

The development of new surgical techniques such as uni or bilateral laminotomies, which are less radical, has made it possible to avoid some arthrodeses. Nowadays, the emergence of new surgical techniques such as endoscopy has further reduced the risk of destabilization (shorter post-operative convalescence, less atrophy of the paraspinal muscles) and improved surgeon comfort (better vision and easier instrument handling).

Unilateral biportal endoscopy (UBE) is one of two endoscopic techniques and has proven its effectiveness for lumbar decompression in terms of clinical benefits. However, there is no scientific evidence on spinal stability after recalibration under UBE.

We believe that minimizing invasiveness with UBE during simple lumbar recalibration surgery can preserve spinal stability, thereby reducing the need for lumbar fixation and lowering the cost of care.

We therefore propose to study the maintenance of spinal stability using dynamic radiography at 3 months post-operatively in patients undergoing lumbar recalibration surgery with UBE.

详细描述

Spinal stability is defined by the absence of abnormal mobility (sagittal translation of at least 3 mm) between flexion and extension movements and will be assessed on the 3-months postoperative dynamic radiography.

Patients will undergone an additional dynamic radiography 3 months after surgery to assess their spinal stability.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Patient ≥ 50 ans,
  • Patient requiring single-level or 2-levels lumbar decompression surgery under UBE,
  • Patients who underwent dynamic radiography within 3 months prior to surgery,
  • Patient who received information on the study and who signed the consent form.

排除标准

  • Presence of a mobile spondylolisthesis with a ≥ 3 mm difference between flexion and extension movements on preoperative dynamic radiography,
  • Patient with history of lumbar arthrodesis,
  • Patient not available for study follow-up.

结局指标

主要结局

Spinal stability rate

时间窗: 3 months

absence of abnormal vertebral mobility

次要结局

  • Spondylolisthesis rate(3 months)
  • Oswestry Disability index evaluation(3 months)
  • Perioperative complications rate(1 day)
  • Pain evaluation(3 months)
  • Vertebral mobility evaluation(3 months)

研究者

发起方
Clinique Saint Jean, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillaume LONJON

Principal Investigator

Clinique Saint Jean, France

研究点 (1)

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