Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 489
- 试验地点
- 1
- 主要终点
- Proportions of patients reaching MCID for NRS leg at 1 year
研究概览
简要总结
Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available.
This study will involve multiple phases to answer specific research questions comparing anterior and posterior interbody fusion in patients with lumbar isthmic spondylolisthesis. The primary end point will be 1-year proportions of patients reaching minimal clinically important difference (MCID) in terms of leg pain measured by NRS leg. The secondary endpoints will be predetermined moderate to severe AEs, reoperations for nonunion, symptomatic adjacent segment disease, radiological alignment correction and correlation with HRQOL as well as economic analysis at 1, 2, 5 and 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18 years or older (or who have reached the age of majority in the participating province)
- •Require surgical treatment for a diagnosis of single-level lumbar isthmic spondylolisthesis, any grade, in the lumbar and lumbosacral spine.
- •Are able to communicate in English or French
- •Anterior interbody fusion group will be defined as having had an anterior or oblique approach with a synthetic cage insertion, interbody bone graft without cage or plate-screw construct with or without posterior rod-screw construct
- •Posterior interbody fusion group will have only posterior approach procedure.
排除标准
- •Previous spinal surgery
- •Specific pathology at level above and below:
- •Degenerative anterolisthesis
- •Pars defect above or below index level
结局指标
主要结局
Proportions of patients reaching MCID for NRS leg at 1 year
时间窗: at 1 year follow-up
Proportions of patients reaching MCID for NRS leg (\>=3)
次要结局
- Change in Patient's reported outcome (PRO) : Oswestry disability index(1 year- 2 year -5 year -10 year follow-up data)
- Change in Patient's reported outcome (PRO) : Patient Health Questionnaire Depression Scale (PHQ-8)(1 year- 2 year -5 year -10 year follow-up data)
- Reoperation due to nonunion at index level or adjacent segment disease(1 year- 2 year -5 year -10 year follow-up data)
- Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)(1 year- 2 year -5 year -10 year follow-up data)
- Proportion of patients with any predefined adverse events(3 month follow-up data)
- Change in radiological parameters(1 year- 2 year -5 year -10 year follow-up data)
- Correlation between improvement in radiological parameters and patient reported outcomes(1 year- 2 year -5 year -10 year follow-up data)
- Change in Patient's reported outcome (PRO) : Numeric pain rating scale for back pain(1 year- 2 year -5 year -10 year follow-up data)
- Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)(1 year- 2 year -5 year -10 year follow-up data)
研究者
Charlotte Dandurand
Spinal Neurosurgeon
University of British Columbia