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临床试验/NCT02290314
NCT02290314Unknown不适用

Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis

The London Spine Centre4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年12月1日最近更新:
适应症

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

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

发起方
The London Spine Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Christopher Bailey

Dr. Christopher Bailey

The London Spine Centre

研究点 (4)

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