Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Physical Function, short form 10a (SF10a)
研究概览
简要总结
Adjacent segment disease (ASD) in the lumbar spine is a well-known sequela of lumbar fusion surgery. The annual incidence of adjacent level re-operation is approximately 3% with a ten-year prevalence of 20-30%. Frequently, the surgical treatment involves decompression of the adjacent level coupled with extension of the instrumentation and fusion. Advocates of this paradigm cite the altered kinematics and biomechanics of levels adjacent to a lumbar fusion mass. Furthermore, decompressed levels adjacent to a fused segments are associated with higher rates of ASD in retrospective studies. Yet, a retrospective review of higher quality data concluded decompression adjacent to single-level fusion provides similar outcomes compared to fusions extending across the decompressed segments.
Given the conflicting data currently available, higher quality data are needed to guide surgical decision-making in ASD. The purpose of this trial is to prospectively compare decompression and decompression with fusion in patients with lumbar ASD.
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
- •Adult patients at least one year removed from a previous instrumented posterior lumbar fusion
- •Patients with any prior posterior fusion involving L2 to the sacrum, whether single-level or multilevel
- •Patients with symptoms related to central and lateral recess at the supradjacent level that have persisted despite at least six weeks of non-operative therapy modalities
排除标准
- •Patients with previous uninstrumented lumbar fusions
- •Patients with traumatic, neoplastic, or infectious etiologies at the adjacent segment
- •Patients with prior iliac or sacroiliac fixation and those with nonunion as the primary indication for surgery
- •Patients with pre-existing instability at the supradjacent level. The definition of instability will be determined based on standing lateral, flexion and extension plain radiographs. Patients with >3mm of change between these views will be excluded.
- •Retrolisthesis will not be a criterion for exclusion
结局指标
主要结局
Physical Function, short form 10a (SF10a)
时间窗: 3 months, 6 months, 1 year, and 2 years post-operation
Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 0-62 (higher score = better outcome)
Global Health, Physical
时间窗: 3 months, 6 months, 1 year, and 2 years post-operation
Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 16-68 (higher score = better outcome)
次要结局
- Global Health, Mental(3 months, 6 months, 1 year, and 2 years post-operation)
- Anxiety, short form 4a (SF4a)(3 months, 6 months, 1 year, and 2 years post-operation)
- Depression, short form 4a (SF4a)(3 months, 6 months, 1 year, and 2 years post-operation)
- Pain interference, short form 4a (SF4a)(3 months, 6 months, 1 year, and 2 years post-operation)
- Hospital length of stay(3 months, 6 months, 1 year, and 2 years post-operation)
- Post-operative narcotic utilization(3 months, 6 months, 1 year, and 2 years post-operation)
- Pain intensity, short form 3a (SF3a)(3 months, 6 months, 1 year, and 2 years post-operation)
- Post-operative complication(3 months, 6 months, 1 year, and 2 years post-operation)
研究者
Daniel G.Tobert, M.D.
Principle Investigator
Massachusetts General Hospital