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

This study has been terminated.
(analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group)
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00546949
First received: October 18, 2007
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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 Intervention
Lumbar Spinal Stenosis
Radiculopathy
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:


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

Primary Outcome Measures:
  • Claudication [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Zürich Claudication Questionnaire


Secondary Outcome Measures:
  • self-evaluated health condition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale


Enrollment: 99
Study Start Date: March 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: 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: October 9, 2013
Health Authority: Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on April 17, 2014