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

Primary Purpose

Lumbar Spinal Stenosis, Radiculopathy

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Minimal invasive decompression
Interspinous Process Decompression (IPD)
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Decompression, Surgical, x-stop, lumbar decompression, spinal stenosis, radiculopathy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nastional Senter for Spinal Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

decompression

x-stop

Arm Description

Minimal invasive decompression

X-stop, an interspinous decompression device

Outcomes

Primary Outcome Measures

Claudication
Zürich Claudication Questionnaire

Secondary Outcome Measures

self-evaluated health condition
SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale

Full Information

First Posted
October 18, 2007
Last Updated
February 24, 2016
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00546949
Brief Title
Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop
Acronym
LSSS
Official Title
Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Radiculopathy
Keywords
Decompression, Surgical, x-stop, lumbar decompression, spinal stenosis, radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
decompression
Arm Type
Active Comparator
Arm Description
Minimal invasive decompression
Arm Title
x-stop
Arm Type
Experimental
Arm Description
X-stop, an interspinous decompression device
Intervention Type
Procedure
Intervention Name(s)
Minimal invasive decompression
Other Intervention Name(s)
mini-invasive decompression
Intervention Description
foraminotomy, laminotomy, microscopic decompression
Intervention Type
Procedure
Intervention Name(s)
Interspinous Process Decompression (IPD)
Other Intervention Name(s)
X-stop
Intervention Description
Interspinous device
Primary Outcome Measure Information:
Title
Claudication
Description
Zürich Claudication Questionnaire
Time Frame
2 years
Secondary Outcome Measure Information:
Title
self-evaluated health condition
Description
SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greger Lønne, MD
Organizational Affiliation
Norwegian University of Sciense and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nastional Senter for Spinal Disorders
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25575084
Citation
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.
Results Reference
result
PubMed Identifier
25608246
Citation
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.
Results Reference
result

Learn more about this trial

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

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