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

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ClinicalTrials.gov Identifier: NCT00546949
Recruitment Status : Terminated (analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group)
First Posted : October 19, 2007
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Radiculopathy Procedure: Minimal invasive decompression Procedure: Interspinous Process Decompression (IPD) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : March 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: decompression
Minimal invasive decompression
Procedure: Minimal invasive decompression
foraminotomy, laminotomy, microscopic decompression
Other Name: mini-invasive decompression
Experimental: x-stop
X-stop, an interspinous decompression device
Procedure: Interspinous Process Decompression (IPD)
Interspinous device
Other Name: X-stop



Primary Outcome Measures :
  1. Claudication [ Time Frame: 2 years ]
    Zürich Claudication Questionnaire


Secondary Outcome Measures :
  1. self-evaluated health condition [ Time Frame: 2 years ]
    SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546949


Locations
Norway
Nastional Senter for Spinal Disorders
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Greger Lønne, MD Norwegian University of Sciense and Technology

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00546949     History of Changes
Other Study ID Numbers: NSSL-16279
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Norwegian University of Science and Technology:
Decompression, Surgical
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