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临床试验/NCT02129374
NCT02129374已完成不适用

Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2014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
163
试验地点
1
主要终点
Union rate using dynamic radiographs and CT scans

研究概览

简要总结

Lumbar spondylolysis is a relatively common condition that causes severe and perennial back pain in young populations. Conservative treatment of this condition may be futile, and may eventually require surgical treatment such as direct repair of pars defect and a segmental lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment methods for spondylolysis, direct repair surgery of pars defect has been focused due to its inherited strengths. Most importantly, fusion surgery caused the affected segment to lose the nature range of motion and furthermore adjacent segment to be adversely affecting such as adjacent disc disease or degeneration, while direct repair theoretically could preserve the motion of the affected segment, which do not cause the adjacent segment problems as being the fusion surgery, as well as could produce better surgical outcomes with relatively less invasive technique as compared to fusion surgery. Moreover, previous articles have demonstrated that the direct repair surgery for spondylolysis of lumbar spine could achieve great functional and radiological outcomes. However, most of the previous studies was conducted using lower level designed study such as retrospective and small sample size, thereby prior literature does not provide clear information on the therapeutic outcome of direct repair for lumbar spondylolysis, especially for managing spondylolysis of young population.

Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair surgery for lumbar spondylolysis in young population. To our knowledge, this is the first report that describes the functional and radiological outcomes of direct repair for spondylolysis in young populations with prospective cohort study design and relatively large sample size.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients for whom conservative treatment for six months and three-times injection treatments had failed
  • a follow-up period of one year or more after surgery

排除标准

  • patients with abnormal muscle activity or ambulation such as parkinsonism and neuromuscular disease.
  • patient inability to accurately record results of preoperative and postoperative questionnaires due to problems such as a history of stroke, dementia, or major medical illness that required intensive treatment
  • patient follow-up was limited to one year or less

结局指标

主要结局

Union rate using dynamic radiographs and CT scans

时间窗: Postoperative 1 year

union rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.

次要结局

  • Pain intensity on VAS(postoperative 12 months)
  • Functional outcome on ODI and SF-12(Postoperative 12 months)

研究者

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

Jin S. Yeom

Associated Professor

Seoul National University Hospital

研究点 (1)

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