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

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

This study is currently recruiting participants.

Verified August 2011 by Norwegian University of Science and Technology

First Received on October 18, 2007. Last Updated on August 9, 2011 History of Changes

Sponsor:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00546949

Purpose

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.

Condition	Intervention
Lumbar Spinal Stenosis Radiculopathy Decompression, Surgical	Procedure: Minimal invasive decompression Procedure: Interspinous Process Decompression (IPD)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)

Resource links provided by NLM:

MedlinePlus related topics: Spinal Stenosis

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	180
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Minimal invasive decompression	Procedure: Minimal invasive decompression foraminotomy, arcotomy, microscopic decompression Other Name: mini-invasive decompression
Active Comparator: 2 X-stop, an interspinous decompression device	Procedure: Interspinous Process Decompression (IPD) Interspinous device Other Name: X-stop

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546949

Contacts

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

Locations

Norway
Nastional Senter for Spinal Disorders	Recruiting
Trondheim, Norway, 7006
Contact: Øystein Nygaard, PhD +4773866687 oystein.nygaard@ntnu.no

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Principal Investigator:

Greger Lønne, MD

Norwegian University of Sciense and Technology

More Information

Additional Information:

Nasjonalt Senter for Spinale Lidelser This link exits the ClinicalTrials.gov site

Lumbal Spinal Stenose Studien This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Oystein Nygaard, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00546949 History of Changes
Other Study ID Numbers:	NSSL-16279
Study First Received:	October 18, 2007
Last Updated:	August 9, 2011
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

x-stop
lumbar decompression
spinal stenosis
radiculopathy

Additional relevant MeSH terms:

Constriction, Pathologic
Spinal Stenosis
Radiculopathy
Pathological Conditions, Anatomical
Spinal Diseases

Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012