A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- ODI, Oswestry Disability Index
研究概览
简要总结
Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.
详细描述
A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed.
Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
- •The patient should be able to understand swedish written and spoken.
- •The patient should be between the ages 18-
- •The patient has to accept to participate in the study
排除标准
- •More than two degenerated segments.
- •Degeneration above the L4 segment.
- •Did not agree to participate in the study
- •Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
- •Need for posterior decompression
- •Pregnancy
- •Psychiatric illness or drug abuse
结局指标
主要结局
ODI, Oswestry Disability Index
时间窗: Two years
ODI questionnaire. ODI (Oswestry disability index, self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, 0-5 zero indicating the least amount of disability and 5 indicating most severe disability)
次要结局
- VAS, Visual Analogue Scale(Two years)
- Segment Mobility(Two years)
- Patient reported back pain after two years in Swespine national registry(Two years)
研究者
Svante Berg
MD, PhD
Karolinska Institutet