"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis - A Prospective Randomized Clinical Study"
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires
研究概览
简要总结
The purpose of this study is to determine whether instrumented lumbar fusion provides superior clinical outcomes in comparison to non-instrumented fusion in patients with "static" degenerative spondylolisthesis.
详细描述
This study will determine whether instrumented lumbar fusion will provide superior clinical outcomes in comparison to non-instrumented fusion in patients with "STATIC" degenerative spondylolisthesis. At the time of scheduling surgery, patients who meet the inclusion/exclusion criteria will be asked to participate. Patients who agree, will be randomized to either non-instrumented or instrumented arthrodesis group. Intra-operative, peri-operative, and post-operative data will be collected and compared. The investigators predict to get very similar clinical outcomes between the two groups, with possibly less complications from the non-instrumented group and definitely a reduction in cost compared to the instrumented group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.
- •Patients with concomitant spinal stenosis.
- •Laminectomy at any lumbar levels of stenosis.
- •Fusion only at L4-5 level.
排除标准
- •Prior lumbar spine surgery
- •Multi-level spondylolisthesis
- •Anterior interbody work/fusion
研究组 & 干预措施
instrumented arthrodesis
Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion with use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention.
干预措施: instrumented spinal fusion with laminectomy (Procedure)
non-instrumented arthrodesis
Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion without the use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention.
干预措施: non-instrumented spinal fusion with laminectomy (Procedure)
结局指标
主要结局
Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires
时间窗: Up to 2 years
Measured by patient outcome survey such as the SF-12 or SF-36 Questionnaire (all questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible)
Functional Outcome Scores: Oswestry Disability Index (ODI) Questionnaire
时间窗: Up to 2 years
Measured by patient outcome survey such as the Oswestry Disability Index (ODI) that assesses low back pain (scoring ranges from 0 to \>35)
次要结局
- Length of Hospital Stay(Expected average of 1 week)
- Surgical Time(2-4 hours)
- Rate of Infection(Expected average of 4 weeks)
- Rate of Symptomatic Pseudoarthrosis(Up to 2 years)
- Need for Revision Surgery(Up to 2 years)
研究者
Joon Yung Lee, MD
M.D.
University of Pittsburgh