Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 148
- 主要终点
- Revision rate
研究概览
简要总结
To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.
详细描述
Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1. Pedicle screws for posterior Instrumentation and fusion of the lumbar spine plus intervertebral fusion L5/S1 (anterior lumbar inter body fusion (ALIF), transforaminal lumbar inter body fusion (TLIF), or posterior lumbar inter body fusion (PLIF)) with
- Caudal end of the instrumentation at S1
- Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
Stratification of both groups by:
- Number of instrumented levels
- Sagittal balance (Roussouly type 1+2 vs. 3+4)
Prospective, randomized, controlled, rater-blinded multicentric interventional study with two parallel groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1
- •Lumbar or thoracolumbar Instrumentation
- •Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1
- •Age ≥ 18 years
排除标准
- •Scoliosis >20°
- •Chronic steroid usage
- •Significant co-morbidity influencing the surgical success:
- •Osteoporosis
- •Rheumatoid arthritis
- •Mental illness/dementia
结局指标
主要结局
Revision rate
时间窗: 1 year after surgery
Revisions rates between groups 1 year after surgery
次要结局
- Adverse events(3, 6, 12, and 24 months after surgery)
- Progressive degeneration of the adjacent segment(3, 6, 12, and 24 months after surgery)
- Health-related quality of life(3, 6, 12, and 24 months after surgery)
- Sacroiliac joint syndrome(3, 6, 12, and 24 months after surgery)
- Surgery duration(Surgery)
- Inter-group Oswestry disability index (ODI)(3, 6, 12, and 24 months after surgery)
- British Medical Research Council (BMRC) scale(3, 6, 12, and 24 months after surgery)
- Intra-group Oswestry disability index (ODI)(3, 6, 12, and 24 months after surgery)
- Revision rate II(24 months after surgery)
- Intraoperative blood loss(Intraoperative)
- Severe adverse events(3, 6, 12, and 24 months after surgery)
- Back pain intensity(3, 6, 12, and 24 months after surgery)
- Gluteal pain(3, 6, 12, and 24 months after surgery)
- Changes in sagittal balance(1 and 2 years after surgery)
- Patient satisfaction(3, 6, 12, and 24 months after surgery)