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The NORDSTEN Studies/ The Spinal Stenosis Study

NCT02007083 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2020-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

PROCEDURE

Bilateral laminotomy (BL)

PROCEDURE

Unilateral laminotomy with crossover (UL)

PROCEDURE

Spinous Process Osteotomy (SPO)

Sponsors & Collaborators

  • Møre og Romsdal Hospital Trust

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Kari Indrekvam Indrekvam, MD, Dr Med · The Coastal Hospital of Hagevik, Orthopeadic Clinic, Haukeland University City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2028-10-31
Completion
2028-12-31

Countries

  • Norway

Study Locations

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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 NCT02007083 on ClinicalTrials.gov