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临床试验/NCT04166981
NCT04166981已完成不适用

Instrumented vs. Non-instrumented Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis

Spine Centre of Southern Denmark2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
2
主要终点
Oswestry Disability Index(ODI)

研究概览

简要总结

The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.

详细描述

Lumbar spinal stenosis (LSS) is a common disease with a large impact on the quality of life of the patient. LSS is defined as narrowing of the spinal canal, nerve root canal or intervertebral foramina. Spinal stenosis is caused by degenerative changes in the lumbar spine, including thickening of the ligamentum flavum, osteophyte formation and disc protrusion. Pain is worse with standing upright and with exercise, and relieved with spine flexion or sitting down.

In the Wakayama Spine Study, investigators found radiographic severe spinal stenosis, defined as narrowing of more than two-thirds of the spinal canal area, in 30,4% of all patients, but only 17,5% were symptomatic.

Many of the patients suffering from LSS are pensioners, with an average age of 65 years. With current changes in demographics and the aging global population it is estimated that prevalence of LSS will increase to nearly 60% by 2025.

In a Danish epidemiological study, degenerative spondylolisthesis was found in 2,7% of men and 8,4% of women above 50 years. Every year, more than 3500 patients aged 60 and above are referred to Center of Spine Surgery Middelfart for LSS. According to the national Danish surgical spine database, DaneSpine, 7936 patients with LSS had surgery during a period from 2009-2013.

Patients suffering from LSS and instability are treated with decompression and posterolateral spinal fusion with or without instrumentation. According to DaneSpine, this group of patients showed improvements on both physical and psychological parameters. In countries outside of Scandinavia, these patients are usually treated with decompression and posterolateral spinal fusion with supplementary pedicle screw fixation. Instrumentation with pedicle screws and rods provides an internal splint, preventing motion during fusion healing. The fusion rate in non-instrumented arthrodesis is reported to be as low as 30-45% In contrast the fusion rate with instrumented arthrodesis have been reported to be above 80%. Although some studies have shown similar outcomes after decompression with or without instrumentation, long-term follow up has shown that a solid fusion improves clinical outcome.

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 (Investigator, Outcomes Assessor)

盲法说明

Investigator and outcome assessors are blinded for treatment allocation.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Lumbar Spinal stenosis, with neurogenic claudication, radicular pain and,
  • Confirmatory MRI scan showing lumbar spinal stenosis on 1-2 levels from L1-S1
  • Standing X-ray showing grade 1 spondylolisthesis on one level
  • Age 60 and above
  • Symptom duration of 3+ months

排除标准

  • Stenosis caused by herniated disc
  • Prior vertebral compression fracture in the affected segments
  • Active malignancy
  • Current fracture, infection og deformity of the spine
  • Stenosis on 3 or more levels
  • MMSE test score below 24
  • Neuromuscular disease
  • Obligatory peroral steroid treatment
  • ASA grade 3 or more.

结局指标

主要结局

Oswestry Disability Index(ODI)

时间窗: 2 years after surgery

A disease specific measure of physical disability in an index score ranging from 0-100, 0 being the best possible outcome and 100 being the worst. Comparing the effectiveness of the two arms.

次要结局

  • Difference in cost-effectiveness between instrumented versus non-instrumented fusion.(2 years after surgery.)
  • European Quality of life - 5 Dimensions (EQ-5D)(preoperative, 3, 12 and 24 months after surgery)
  • Achieved solid posterolateral fusion(CT-scans 1 year after surgery)
  • Change in sagittal balance, effect on outcome.(Pre operative, 1 and 2 years after surgery)

研究者

发起方
Spine Centre of Southern Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Kiilerich Andresen

Study Principal Investigator

Spine Centre of Southern Denmark

研究点 (2)

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