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临床试验/NCT05246241
NCT05246241已完成不适用

Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence Following Surgical Repair

Ataturk University1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2021年4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
188
试验地点
1
主要终点
Paraspinal muscle quality

研究概览

简要总结

There are currently no standard criteria for evaluating the risk of recurrent disk herniation following surgical repair. This study investigated the predictive values of five presurgical imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified Pfirrmann's disc degeneration grade, and presence of sacralization or fusion.

Clinical status and MRI findings were evaluated before surgery and 4, 12, and 24 months post-surgery using a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Short Form 36 (SF36).

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • first operation for a single-level lumbar disk herniation
  • no concurrent spinal pathology such as stenosis, spondylolisthesis, or deformity
  • complete data on clinical and radiological parameters

排除标准

  • the operation was for multi-level pathologies
  • recurrent surgery
  • exhibited concurrent spinal pathology
  • was missing or incomplete clinical and radiological data

结局指标

主要结局

Paraspinal muscle quality

时间窗: Preoperative 1 month

Simplified 3-tier classification

Annular tear size

时间窗: Preoperative 1 month

With computer as millimeter

Modic changes

时间窗: Preoperative 1 month

Modic classification

Disc degeneration grade

时间窗: Preoperative 1 month

modified Pfirrmann's classification

sacralization or fusion

时间窗: Preoperative 1 month

MRI findings

次要结局

  • Oswestry Disability Index (ODI)(4, 12, and 24 months after surgery)
  • Visual Analog Scale(4, 12, and 24 months after surgery)
  • Short Form 36 (SF36)(4, 12, and 24 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Kursat Karadag

Principal Investigator

Ataturk University

研究点 (1)

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