Supplemental Anterior Lumbar Interbody Fusion in Posterior Instrumented Fusion in Surgical Treatment of Spinal Deformities. A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Revision
研究概览
简要总结
Within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. This is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region.
The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •18 years or more of age
- •planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium
排除标准
- •malignancy
- •infection
研究组 & 干预措施
Anterior lumbar interbody fusion
Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.
干预措施: Tantalum cage from Zimmer (Device)
Posterior instrumentation alone
Posterior pedicle screw instrumentation
干预措施: Tantalum cage from Zimmer (Device)
结局指标
主要结局
Revision
时间窗: 12 months
Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure
次要结局
未报告次要终点
研究者
Benny Dahl, MD, PhD
Professor of Spine Surgery
Rigshospitalet, Denmark