Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Time to discharge
研究概览
简要总结
Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. Recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. However, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. This pilot study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to traditional "open" posterior lumbar interbody fusion (PLIF) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.
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
- 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
- •Patients attending Victoria Hospital
- •Degenerative spondylolisthesis in the lumbar spine at one level
- •Medically Suitable for surgical management
- •Able to consent for surgery
排除标准
- •Lytic spondylolisthesis
- •Non degenerative stenosis: tumor, trauma
- •Active infection
- •On long term disability or workers compensation claims
- •Drug or alcohol misuse
- •Lack of permanent home residence
- •Previous surgery in the lumbar spine at the surgical level
- •Previous fusion in the lumbar spine
- •Contraindication to surgery: medical co morbidities
- •Unable to complete questionnaire: eg dementia
- •Unable to give voluntary consent
结局指标
主要结局
Time to discharge
时间窗: Length of inhospital stay after surgery - average 4 days
次要结局
- Approach-related in-hospital morbidity(At time of index surgery)
- Cost-effectiveness of the two surgical approaches(Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years)
- Oswestry Disability Index(Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years)
研究者
Dr. Christopher Bailey
Dr. Christopher Bailey
The London Spine Centre
