Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

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

COMPLETED

Total Enrollment

721 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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Introduction: This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. Many spine surgeons today perform microdecompression for central lumbar spinal stenosis.

Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery (NORspine).

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Detailed Description

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Conditions

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Spinal Stenosis Spinal Cord Compression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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microdecompression

surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms.

microdecompression

Intervention Type PROCEDURE

a minimal invasive surgical technique

laminectomy

the spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected

laminectomy

Intervention Type PROCEDURE

The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets

Interventions

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microdecompression

a minimal invasive surgical technique

Intervention Type PROCEDURE

laminectomy

The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of central lumbar spinal stenosis
* Operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in the time period between October 2006 and December 2011
* Included in the NORspine registry

Exclusion Criteria

* History of lumbar fusion
* Previous surgery in the lumbar spine
* Discectomy as part of the decompression
* Associated pathological entities such as disc herniation, spondylolisthesis or scoliosis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No