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临床试验/NCT04886557
NCT04886557已完成不适用

Retrospective Image Analysis of Degenerative Lumbar Disease Patients

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
主要终点
Range of motion

研究概览

简要总结

The Dynesys dynamic stabilization (DDS) system is considered a motion-preserving device. However, studies addressing the change in the range of motion (ROM) are limited. Therefore, this study aimed to investigate the factors influencing ROM change at the index surgical level, supra-index level, and whole lumbar spine, in addition to the association between ROM preservation and the incidence of screw-loosening.

详细描述

Decompression with instrumented fusion is an effective surgical intervention for lumbar degenerative spondylolisthesis with spinal stenosis. However, the range of motion (ROM) decreased at the index surgical level may lead to an increased ROM at the non-surgical level, increase biomechanical stress at the transitional adjacent segment, and lead to adjacent segment degeneration (ASD) .

The Dynesys dynamic stabilization (DDS) system is a pedicle screw-based, motion-preserving, and non-fusion stabilization developed as an alternative to the rigid instrumented fusion for degenerative spondylolisthesis. The aim of the DDS is to maintain segmental motion at index levels and to reduce the incidence of ASD. However, the actual impact of ROM has remained elusive. Prior studies have reported an average ROM loss of 1.1º to 17.3º 7 at index surgical level at an average of 24 months follow-up.

The change of ROM at index surgical, supra-index, and whole lumbar spine following DDS remains unclear. This study aims to investigate the factors influencing the ROM change at index surgical level, supra-index level, and whole lumbar spine, and the association between ROM preservation and the incidence of screw-loosening.

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

  • Adult patients
  • Diagnosed with degenerative spondylolisthesis over L4-L5
  • Received DDS
  • Received a minimum of 2-year follow-up were reviewed.

排除标准

  • presence of degenerative scoliosis or spinal deformity,
  • prior spine surgery,
  • lost to follow-up, or
  • failure to complete the questionnaires or radiographic examinations.

结局指标

主要结局

Range of motion

时间窗: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.

The ROM change at index surgical level, supra-index level, and whole lumbar spine in degenerative lumbar diseased patients received dynesys dynamic instrumentation

次要结局

  • Screw loosening(All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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