跳至主要内容
临床试验/NCT01921530
NCT01921530Unknown4 期

Interbody Fusion and Decompression Versus Instrumented Posterolateral Fusion and Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

The London Spine Centre2 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
178
试验地点
2
主要终点
Oswestry Disability Index

研究概览

简要总结

Degenerative spondylolisthesis describes the slip of one spinal segment relative to the adjacent segment. It is usually associated with spinal stenosis (which limits one's ability to walk and stand) and is the most common indication for surgery in adults over age 65 years. A variety of surgical techniques are available; the most common are the Posterolateral Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed within the cleaned out disc space between the vertebral bodies being fused. Although this approach achieves a good fusion rate and deformity correction it is associated with a higher surgical cost and potential intra-operative complication rate. What is more, no consensus exists as to whether IF provides better patient rated functional outcome and quality of life. If the advantages of IF do not translate into superior patient rated outcomes, then the risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The investigators will conduct a prospective randomized control trial comparing these two procedures. Our primary outcome measure will be the Oswestry Disability Index, which evaluates spinal pain and function.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 50 years or older
  • Grade I or II (less than 50% slip of the cephalad vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L
  • Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of non surgical treatment
  • Patients who are medically suitable for surgical management
  • Patients who have consented for surgical treatment
  • Patients able to provide informed consent for the study and complete the questionnaires

排除标准

  • Lytic spondylolisthesis
  • Non degenerative stenosis (example: tumor, trauma, epidural lipomatosis)
  • Severe vertical foraminal stenosis necessitating interbody insertion to re-establish foraminal height
  • Segmental kyphosis at the level of the spondylolisthesis
  • Segmental scoliosis >10 degrees at the level of the spondylolisthesis
  • Rheumatoid arthritis
  • Active infection
  • On long term disability or workers compensation claim
  • Drug or alcohol misuse
  • Lack of permanent home residence
  • Previous surgery at the proposed surgical level
  • Previous fusion in the lumbar spine
  • Contraindication to surgery: medical co morbidities
  • Unable to complete questionnaire (e.g. Dementia)
  • Unable to give voluntary consent

研究组 & 干预措施

Interbody Fusion

Active Comparator

干预措施: Interbody Fusion (Procedure)

Posterolateral Fusion

Active Comparator

干预措施: Posterolateral Fusion (Procedure)

结局指标

主要结局

Oswestry Disability Index

时间窗: 1 year post surgery

The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists.

次要结局

  • Oswestry Disability Index(Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery)

研究者

发起方
The London Spine Centre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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