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

NCT ID: NCT00546949

Last Updated: 2016-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2013-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Lumbar Spinal Stenosis Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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decompression

Minimal invasive decompression

Group Type ACTIVE_COMPARATOR

Minimal invasive decompression

Intervention Type PROCEDURE

foraminotomy, laminotomy, microscopic decompression

x-stop

X-stop, an interspinous decompression device

Group Type EXPERIMENTAL

Interspinous Process Decompression (IPD)

Intervention Type PROCEDURE

Interspinous device

Interventions

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Minimal invasive decompression

foraminotomy, laminotomy, microscopic decompression

Intervention Type PROCEDURE

Interspinous Process Decompression (IPD)

Interspinous device

Intervention Type PROCEDURE

Other Intervention Names

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mini-invasive decompression X-stop

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greger Lønne, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Sciense and Technology

Locations

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Nastional Senter for Spinal Disorders

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 25575084 (View on PubMed)

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.

Reference Type RESULT
PMID: 25608246 (View on PubMed)

Other Identifiers

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NSSL-16279

Identifier Type: -

Identifier Source: org_study_id

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