Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop

Norwegian University of Science and Technology96 enrolled

Overview

The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lumbar Spinal Stenosis Radiculopathy

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * neurogenic intermittent claudication due to lumbar spinal stenosis * diagnosed on MRI in maximum two levels * walking distance on 250 metres * symptom relief on flexion of the lumbar spine * duration of the symptoms more than 6 months * non-operative treatment is tried or considered as not indicated Exclusion Criteria: * vascular claudicatio intermittens * spinal stenosis on more than 2 levels * cauda equina syndrome * severe paresis * clinical monoradiculopathy * grave scoliosis * previous lumbar surgery * degenerative spondylolisthesis more than 25% * spondylolysis with listhesis * osteoporotic fracture in lumbal column * clinical and radiological (both) arthritis in the hip joint * ASA \>3 * verified polyneuropathy on neurophysiological test

Outcomes

Primary Outcomes

Claudication

Zürich Claudication Questionnaire

Time frame: 2 years

Secondary Outcomes

self-evaluated health condition

SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale