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

Tracking Information

First Received Date ^ICMJE

October 18, 2007

Last Updated Date

July 27, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Zürich Claudicatio Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Zürich Claudicatio Questionnaire [ Time Frame: 2 years ]

Change History

Complete list of historical versions of study NCT00546949 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale on pain and self-evaluated health condition,a full economical evaluation, areal measurements on MRI and DCRA (distortion compensated roentgen analyzes) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)

Brief Summary

The purpose of this study is to compare two operation methods on lumbar spinal stenosis; minimal invasive decompression to X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and nevrogenic intermittent claudicatio.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Lumbar Spinal Stenosis
Radiculopathy
Decompression, Surgical

Intervention ^ICMJE

Procedure: Minimal invasive decompression
Procedure: Interspinous Process Decompression (IPD)

Study Arms / Comparison Groups

Active Comparator: Minimal invasive decompression
Active Comparator: X-stop

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

nevrogenic intermittent claudicatio due to lumbar spinal stenosis
diagnosed on MRI in maximum two levels
walking distance on 250 metres
sympthoms is relieved on flexion of the lumbar spine
duration of the symptoms more than 6 month
non-operative treatment is tried or considered as not indicated

Exclusion Criteria:

vascular cladicatio intermittens
spinal stenosis on more than 2 levels
cauda equina syndrom
severe paresis
clinical monoradiculopathy
grave scoliosis
privious lumbar surgery
degenerative spondylolisthesis more than 25%
spondylolysis with listesis
osteoporotic fracture in lumbal column
clinical and radioliogical (both) arthritis in the hip joint
ASA >3
verified polynevropathy on neurophysiological test

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Øystein Nygaard, PhD	+4773866687	oystein.nygaard@ntnu.no
Contact: Hege Andresen	+4790205421	Hege.Andresen@stolav.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00546949

Responsible Party

Oystein Nygaard, Norwegian University of Science and Technology

Study ID Numbers ^ICMJE

NSSL-16279

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Greger Lønne, MD

Norwegian University of Sciense and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP