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

NCT00546949 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2016-02-25

No results posted yet for this study

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)

Conditions

  • Lumbar Spinal Stenosis
  • Radiculopathy

Interventions

PROCEDURE

Minimal invasive decompression

foraminotomy, laminotomy, microscopic decompression

PROCEDURE

Interspinous Process Decompression (IPD)

Interspinous device

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Greger Lønne, MD · Norwegian University of Sciense and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-09-30
Completion
2013-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546949 on ClinicalTrials.gov