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Swedish Spinal Stenosis Study

NCT01994512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2015-12-17

No results posted yet for this study

Summary

A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis \>3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.

Conditions

  • Lumbar Spinal Stenosis

Interventions

PROCEDURE

Decompression without fusion

Decompressive surgery of both central and lateral component of the stenosis.

PROCEDURE

Decompression with fusion

Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-06-30
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994512 on ClinicalTrials.gov