Trial record 5 of 36 for:    Open Studies | "Spinal Stenosis"

The NORDSTEN Studies/ The Spinal Stenosis Study (NORDSTEN/SST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Haukeland University Hospital
Sponsor:
Collaborator:
Møre and Romsdal Hospital Trust.
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT02007083
First received: November 22, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Lumbar Spinal Stenosis.
Procedure: Bilateral laminotomy (BL)
Procedure: Unilateral laminotomy with crossover (UL)
Procedure: Spinous Process Osteotomy (SPO)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Different Surgical Treatments for Lumbar Spinal Stenosis. A Randomized Controlled Trial Comparing the Clinical and Radiological Results Using "Spinous Process Osteotomy", "Bilateral Laminotomy" and "Unilateral Laminotomy With Crossover"

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 2, 5 and 10 years after surgery ] [ Designated as safety issue: No ]

    The investigators will monitor the ODI-index before and after surgery, and calculate the change of ODI after surgery compared to baseline.

    The primary outcome is a measurement of the change of ODI (version 2.0) from baseline in the three different surgical groups. This will be done by calculating the mean ODI improvement in each group. The investigators will also compare the proportion of responders between the SPO group, the BL group and the UL group, 24 months after the operation. The investigators will dichotomize the patients, in a "succesfull outcome group" and in a "non- succesfull outcome group". The threshold value for being categorized as a "succesfull outcome" will be computed in a planned study based on data from The Norwegian Registry for Spine Surgery (NORSpine).

    The investigators also plan to asses short time results after 2 years, intermediate results after 5 years, and long time results after 10 years.



Secondary Outcome Measures:
  • Zurich Claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery. [ Time Frame: 2, 5 and 10 years after surgery ] [ Designated as safety issue: No ]

    All of the above mentioned questionaires are validated and reliable questionaires to asses the effect of surgical treatment. The effect of the surgical treatment is calculated by the improvement of the different scores, and thereby is an objective way to asses the effect of the surgical treatment.

    The investigators plan to asses short time results after 2 years, intermediate results after 5 years, and long time results after 10 years.



Other Outcome Measures:
  • Dural Sac Cross sectional Area (DSCSA) [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    The investigators are planning to investigate the DSCSA before and after surgery. Thereby we can monitor which surgical procedure that increases the DSCSA the most. The investigators will also investigate wether a large increase of the DSCSA is needed to maintain good long-time clinical results.


Estimated Enrollment: 465
Study Start Date: November 2013
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: Bilateral laminotomy (BL)
Other Names:
  • Fenestration procedures.
  • Multile laminotomies.
Active Comparator: Unilateral laminotomi 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.
Procedure: Unilateral laminotomy with crossover (UL)
Other Name: Microdecompression.
Active Comparator: 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.
Procedure: Spinous Process Osteotomy (SPO)
Other Names:
  • Laminarthrectomi.
  • Micro Spinous Process Osteotomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • ODI-score ≥ 25 points.
  • 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 syndrom (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. polynevropathy, vascular claudication or osteoarthtritis.
  • LSS in 4 or more levels.
  • not able to comply fully with the protocol, including treatment, follow-up or study precedures (psychosocially, mentally and physical).
  • the patient is participating in another clinical trial that may interfere with this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007083

Contacts
Contact: Erland Hermansen, MD +47 70105766 erland.hermansen@helse-bergen.no
Contact: Kari Indrekvam, MD Dr.Med +47 56565800 kari.indrekvam@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Hagevik, Norway, 5217
Contact: Erland Hermansen, MD    +47 70105766    erland.hermansen@helse-bergen.no   
Contact: Kari Indrekvam, MD, Dr Med    +47 56565800    kari.indrekvam@helse-bergen.no   
Principal Investigator: Erland Hermansen, MD         
Sponsors and Collaborators
Haukeland University Hospital
Møre and Romsdal Hospital Trust.
Investigators
Study Director: Kari Indrekvam Indrekvam, MD, Dr Med The Coastal Hospital of Hagevik, Orthopeadic Clinic, Haukeland University City
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02007083     History of Changes
Other Study ID Numbers: 2011/2034, 2011/2034
Study First Received: November 22, 2013
Last Updated: December 18, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Lumbar Spinal stenosis.
Surgical treatment of LSS.

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014