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TerminatedNCT00546949LSSSUpdated Feb 25, 2016

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

An interventional study of Minimal invasive decompression and Interspinous Process Decompression (IPD) in Lumbar Spinal Stenosis and Radiculopathy, sponsored by Norwegian University of Science and Technology. Terminated at 1 site in Norway. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

Why this study was terminated
analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
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Study 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)

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Conditions studied

  • Lumbar Spinal Stenosis
  • Radiculopathy

Keywords

  • Decompression, Surgical
  • x-stop
  • lumbar decompression
  • spinal stenosis
  • radiculopathy
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In context

Spinal Stenosis

469 studies on the registry are indexed under Spinal Stenosis; 106 are open to participants now.

This study's enrollment of 96 is above the median of 80 across 289 interventional studies indexed under Spinal Stenosis.

Browse Spinal Stenosis studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 494 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Active comparator
    decompression

    Minimal invasive decompression

    Procedure: Minimal invasive decompression

  • Experimental
    x-stop

    X-stop, an interspinous decompression device

    Procedure: Interspinous Process Decompression (IPD)

Interventions

  • ProcedureMinimal invasive decompression

    foraminotomy, laminotomy, microscopic decompression

    Also known as: mini-invasive decompression

  • ProcedureInterspinous Process Decompression (IPD)

    Interspinous device

    Also known as: X-stop

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What researchers measure

Primary outcomes

  1. Claudication

    Zürich Claudication Questionnaire

    Time frame: 2 years

Secondary outcomes

  1. self-evaluated health condition

    SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale

    Time frame: 2 years

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Study locations

1 site
  • Nastional Senter for Spinal Disorders
    Trondheim, 7006, Norway
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References and documents

Publications

  • Lonne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard OP. Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015 Jan 15;40(2):77-85. doi: 10.1097/BRS.0000000000000691. PubMed 25575084 ↗
  • Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, Nygaard OP. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514-20. doi: 10.1097/BRS.0000000000000798. PubMed 25608246 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00546949
Responsible party
Sponsor
First posted
Oct 19, 2007
Start date
Mar 2007
Primary completion
Sep 2011
Completion
Dec 2013
Last update
Feb 25, 2016

Study contacts

Greger Lønne, MD
principal investigator · Norwegian University of Sciense and Technology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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