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临床试验/NCT05266638
NCT05266638已完成不适用

AgeTLIF - Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2022年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
Number of Implant failure

研究概览

简要总结

This retrospective study is to determine whether age is a risk factor for postoperative complications in patients undergoing transforaminal lumbar interbody fusion; specifically whether the risk (odds) of implant failure and the need for revision surgery increases with age.

详细描述

Spinal fusion is one of the most commonly performed surgical procedures for the treatment of degenerative spinal disease. Interbody fusion with cages reconstructs the anterior column through disc removal, allowing to maintain proper disc height despite weight bearing, while providing firm fixation of the spinal segments. Transforaminal lumbar interbody fusion (TLIF) has fewer complications and less intraoperative bleeding than posterior lumbar interbody fusion (PLIF). Elderly patients are at high risk for perioperative and postoperative complications after lumbar fusion. This retrospective study is to determine whether age is a risk factor for postoperative complications in patients undergoing transforaminal lumbar interbody fusion; specifically whether the risk (odds) of implant failure and the need for revision surgery increases with age.

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
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indications for TLIF surgery (e.g., degenerative disc disease, spondylolisthesis)
  • Existing preoperative upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis, sacrum and femoral head
  • Existing preoperative MRI of the lumbar region with clear visibility of different fatty infiltration grade and stenosis degree
  • Complete follow-up at 3 months and 1 year postoperatively, including clinical and radiographic data

排除标准

  • Neuromuscular diseases such as Parkinson's disease or multiple sclerosis according to our records
  • Preoperative infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the lumbar spine
  • Presence of a documented consent dissent

结局指标

主要结局

Number of Implant failure

时间窗: one time assessment at baseline

Number of Implant failure (screw loosening, cage subsidence, adjacent level alteration/ degeneration, spondylolisthesis degree, kyphosis of the adjacent intervertebral disc space, reduced height of intervertebral disc space) in relationship to age

Number of patients needing revision surgery

时间窗: one time assessment at baseline

Number of patients needing revision surgery, in relationship to age

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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