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临床试验/NCT03585439
NCT03585439已完成不适用

Isthmic Spondylolisthesis Treated With Circumferential Arthrodesis Combining Anterior Lumbar Interbody Fusion With Posterolateral Fusion. About 150 Cases

CMC Ambroise Paré1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2018年6月28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
87
试验地点
1
主要终点
Fusion status

研究概览

简要总结

This study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. The goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis. There is very little literature concerning this procedure.

详细描述

Isthmic spondylolisthesis can cause back and leg pain. If pain persists after well conducted medical management, a surgical treatment can be proposed. Even though the goal is consensual, there are plenty of ways to reach vertebral fusion: ALIF, PLIF, TLIF, Posterior fusion only, etc... This study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. The goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis using standard XRays, CT Scan and patient reported outcome measurements. There is very little literature concerning this procedure.

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

  • All patients aged over 18 years
  • With isthmic spondylolisthesis at L4-L5 or L5-S1
  • Operated in our center with a double approach: Anterior lumbar interbody fusion then postero-lateral fusion
  • Consent for participation

排除标准

  • Pseudarthrosis L5-S1

结局指标

主要结局

Fusion status

时间窗: From 6 months to 1 year after surgery

Every patient has a CT-Scan of the lumbar spine done to check fusion status. The interpretation is made by the surgeon who did the surgery and one independent reviewer.

次要结局

  • Restoration of the foraminal diameter(3 months and 1 year after surgery)
  • Local Lordosis(3 months and 1 year after surgery)
  • Correction of the spondylolisthesis-induced kyphosis after surgery(3 months and 1 year after surgery)
  • Segmental lordosis(3 months and 1 year after surgery)
  • Back pain(Pre-operative, 3 months and 1 year after surgery)
  • Sciatica(Pre-operative, 3 months and 1 year after surgery)
  • Complication rate(until 1 year after surgery)
  • Disability(Pre-operative, 3 months and 1 year after surgery)

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (1)

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