跳至主要内容
临床试验/CTRI/2024/01/061238
CTRI/2024/01/061238招募中不适用

Are prebent rods ideal: a radiological analysis of lumbar lordosis after single level MIS TLIF at L3-4, L4-5, and L5-S1

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2024年1月13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
385
试验地点
1
主要终点
Lordosis of prebent rod

研究概览

简要总结

Fusion surgery increases spine stiffness and can modify biomechanics and sagittal spinopelvic parameters. Restoration of sagittal balance is a key issue in lumbar fusion surgery. Inadequate sagittal plane correction has been associated with adverse postoperative outcomes. Thus maintainence or restoration of the sagittal plane spinal alignment forms an important aspect of the lumbar fusion surgery.

An important step of surgical planning involves the understanding of segmental contributions of different levels in the sagittal alignment of the spine. Majority of lumbar lordosis is present at the caudal 2 motion segments. The distribution of the lordosis in the lower (L4-S1) and upper (L1-L3) arcs is important as it alters the distribution of loads. Thus, a maldistribution of lordosis may result in mechanical complications in the post-operative period.

研究设计

研究类型
Observational

入排标准

年龄范围
10.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing a single-level Minimally invasive TLIF procedure for the treatment of a single-level degenerative lumbar condition will be included in the study.

排除标准

  • Patients undergoing more than one level of surgery Patients undergoing fusion for a non-degenerative condition(deformity, tumor, trauma or infection) Patients undergoing fusion for high-grade spondylolisthesis.

结局指标

主要结局

Lordosis of prebent rod

时间窗: No follow up visit

Total Lumbar Lordosis - pre-operative and post-operative (Day 3)

时间窗: No follow up visit

Segmental Lordosis achieved at the fusion level

时间窗: No follow up visit

次要结局

  • NA(NA)

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bharat R Dave

Stavya Spine Hospital And Research Institute

研究点 (1)

Loading locations...

相似试验