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

Not Applicable

Terminated

• Conditions: Radiculopathy; Lumbar Spinal Stenosis
• Interventions: Procedure: Minimal invasive decompression; Procedure: Interspinous Process Decompression (IPD)

• Registration Number: NCT00546949
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Primary Completion: 2011-09
• Study Completion: 2013-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
decompression	Minimal invasive decompression	Minimal invasive decompression
x-stop	Interspinous Process Decompression (IPD)	X-stop, an interspinous decompression device

Primary Outcome Measures

Name	Time	Method
Claudication	2 years	Zürich Claudication Questionnaire

Secondary Outcome Measures

Name	Time	Method
self-evaluated health condition	2 years	SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale

Trial Locations

Locations (1)

Nastional Senter for Spinal Disorders; 🇳🇴 Trondheim, Norway