The NORDSTEN Studies/ The Spinal Stenosis Study

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2028-12-31

Brief Summary

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Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a compression of the the neural and vascular structures in the spinal canal. This often gives neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical treatment is well documented by several clinical trials, and a Cochrane review article from 2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the literature of which surgical method that gives best long term clinical results. The investigators are therefore planning a Randomized Controlled Trial, where they will compare clinical and radiological results of three different surgical methods for LSS. The main outcome of this study is to answer which surgical method that gives the best long term clinical results. And, secondary outcome is to find out how much increase of the Dural Sac Cross Sectional Area is needed to give a long time relief of the patients' symptoms.

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Detailed Description

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Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bilateral laminotomy (BL)

The multifidus muscles is detached from the spinous process bilaterally.The decompression of the spinal canal is performed by first doing a flavectomy. Thereby performing a laminotomy (about 1/3) of the the lower part of the superior lamina, and a laminotomy of the upper part (about 1/4) of the inferior lamina. This is performed bilaterally.

Group Type ACTIVE_COMPARATOR

Bilateral laminotomy (BL)

Intervention Type PROCEDURE

Unilateral laminotomy with crossover (UL)

The multifidus muscles is detached from the spinous process unilaterally. The laminotomy is first performed ipsilaterally. The decompression of the spinal canal is performed by first doing a flavectomy. Then, performing a laminotomy (about 1/3) of the the lower part of the superior lamina, and a laminotomy of the upper part (about 1/4) of the inferior lamina. Dura is then retracted, and the decompression is performed contralaterally.

Group Type ACTIVE_COMPARATOR

Unilateral laminotomy with crossover (UL)

Intervention Type PROCEDURE

Spinous process osteotomy (SPO)

The multifidus muscles is detached from the spinous process unilaterally. An osteotomy of the superior spinous process is performed at the basis, in the actual level. The spinous process with intact interspinal and supraspinal ligaments is then retracted to the contralateral side. The decompression is first performed in the midline. Then one goes laterally on both sides too perform the decompression. About 1/3 of the lower part of the superior lamina is removed, and about 1/4 of the upper part of the inferior lamina is removed.

Group Type ACTIVE_COMPARATOR

Spinous Process Osteotomy (SPO)

Intervention Type PROCEDURE

Interventions

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Bilateral laminotomy (BL)

Intervention Type PROCEDURE

Unilateral laminotomy with crossover (UL)

Intervention Type PROCEDURE

Spinous Process Osteotomy (SPO)

Intervention Type PROCEDURE

Other Intervention Names

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Fenestration procedures. Multiple laminotomies. microdecompression. Laminarthrectomi. Micro Spinous Process Osteotomy

Eligibility Criteria

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Inclusion Criteria

* have clinical symptoms of spinal stenosis as neurogenic claudication or radiating pain into the bilaterally to the lower limbs, not responding to at least 3 months of conservative treatment.
* Radiological findings corresponding to the clinical symptoms of LSS. Central -stenosis, or lateral recess-stenosis.
* be able to give informed consent and to answer the questionnaires.
* over 18 years of age-have -not responding to at least 3 months of non-surgical treatment.
* be able to understand Norwegian language, spoken and in writing

Exclusion Criteria

* have a degenerative lumbar spondylolisthesis, with a slip ≥ 3 mm verified on standing plain x-rays in lateral view.
* are not willing to give written consent.
* have former surgery in the level of stenosis.
* fracture, or former fusion of the thoracolumbal region.
* cauda equina syndrome (bowel or bladder dysfunction) or fixed complete motor deficit.
* are ASA- classified 4 or 5.
* are older than 80 years
* have a lumbosacral scoliosis more than 20 degrees verified on AP-view
* have distinct symptoms in one or both of their legs due to other diseases, e.g. polyneuropaty, vascular claudication or osteoarthtris.
* LSS in 4 or more levels.
* not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical).
* the patient is participating in another clinical trial that may interfere with this trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No