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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Radiculopathy
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014