PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration Following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- Quality of Life
研究概览
简要总结
A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Although ASD is a common complication following lumbar fusion, the effect of an Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately.
详细描述
Methods From 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years, 17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS and compared with 20 controls (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI. Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI and supradjacent segment disc heights. All spines were preoperatively balanced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 49 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative MRI with degeneration grades<III at the 1st supradjacent lumbar segment.
排除标准
- •Body mass index≥40kg/m*m
- •Severe osteoporosis
- •Lumbar fracture
- •Preoperative SVA>4cm
- •Spondylolisthesis grades>II or spondylolytic lesion and acquired spinous process insufficiency in the supradjacent segment cephalad to instrumentation
研究组 & 干预措施
Control Group
Patients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer
干预措施: PEEK interspinous spacer (Procedure)
Peek Group
Patients that received PEEK interspinous spacer
干预措施: PEEK interspinous spacer (Procedure)
Silicon Group
Patients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer
干预措施: PEEK interspinous spacer (Procedure)
结局指标
主要结局
Quality of Life
时间窗: Three years
Oswestry Disability Index scale (0-100)
次要结局
- Disc heights(Three years)
- Sacral Slope(Three years)
- Pain(Three years)
研究者
Vasileios Syrimpeis
Orthopaedic Surgeon
University Hospital of Patras