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

Primary Purpose

Lumbar Spinal Stenosis

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bilateral laminotomy (BL)
Unilateral laminotomy with crossover (UL)
Spinous Process Osteotomy (SPO)
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Lumbar Spinal stenosis, Surgical treatment of LSS.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bilateral laminotomy (BL)

Unilateral laminotomy with crossover (UL)

Spinous process osteotomy (SPO)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Oswestry Disability Index
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 "success patients" between the SPO group, the BL group and the UL group, 24 months after the operation. The investigators will dichotomize the patients, in a "succesful outcome group" and in a "non- succesful outcome group". The threshold value for being categorized as a "succesful 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.
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.

Full Information

First Posted
November 22, 2013
Last Updated
August 11, 2020
Sponsor
Haukeland University Hospital
Collaborators
Møre og Romsdal Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02007083
Brief Title
The NORDSTEN Studies/ The Spinal Stenosis Study
Acronym
NORDSTEN/SST
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"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2013 (Actual)
Primary Completion Date
October 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Møre og Romsdal Hospital Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Lumbar Spinal stenosis, Surgical treatment of LSS.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
465 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral laminotomy (BL)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Unilateral laminotomy with crossover (UL)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Spinous process osteotomy (SPO)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral laminotomy (BL)
Other Intervention Name(s)
Fenestration procedures., Multiple laminotomies.
Intervention Type
Procedure
Intervention Name(s)
Unilateral laminotomy with crossover (UL)
Other Intervention Name(s)
microdecompression.
Intervention Type
Procedure
Intervention Name(s)
Spinous Process Osteotomy (SPO)
Other Intervention Name(s)
Laminarthrectomi., Micro Spinous Process Osteotomy
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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 "success patients" between the SPO group, the BL group and the UL group, 24 months after the operation. The investigators will dichotomize the patients, in a "succesful outcome group" and in a "non- succesful outcome group". The threshold value for being categorized as a "succesful 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.
Time Frame
2, 5 and 10 years after surgery
Secondary Outcome Measure Information:
Title
Zurich claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery.
Description
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.
Time Frame
2, 5 and 10 years after surgery
Other Pre-specified Outcome Measures:
Title
Dural Sac Cross sectional Area (DSCSA)
Description
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.
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Indrekvam Indrekvam, MD, Dr Med
Organizational Affiliation
The Coastal Hospital of Hagevik, Orthopeadic Clinic, Haukeland University City
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
State/Province
Hagevik
ZIP/Postal Code
5217
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35344046
Citation
Hermansen E, Austevoll IM, Hellum C, Storheim K, Myklebust TA, Aaen J, Banitalebi H, Anvar M, Rekeland F, Brox JI, Franssen E, Weber C, Solberg TK, Furunes H, Grundnes O, Brisby H, Indrekvam K. Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e224291. doi: 10.1001/jamanetworkopen.2022.4291.
Results Reference
derived
PubMed Identifier
35033042
Citation
Banitalebi H, Espeland A, Anvar M, Hermansen E, Hellum C, Brox JI, Myklebust TA, Indrekvam K, Brisby H, Weber C, Aaen J, Austevoll IM, Grundnes O, Negard A. Reliability of preoperative MRI findings in patients with lumbar spinal stenosis. BMC Musculoskelet Disord. 2022 Jan 15;23(1):51. doi: 10.1186/s12891-021-04949-4.
Results Reference
derived
PubMed Identifier
34797405
Citation
Aaen J, Austevoll IM, Hellum C, Storheim K, Myklebust TA, Banitalebi H, Anvar M, Brox JI, Weber C, Solberg T, Grundnes O, Brisby H, Indrekvam K, Hermansen E. Clinical and MRI findings in lumbar spinal stenosis: baseline data from the NORDSTEN study. Eur Spine J. 2022 Jun;31(6):1391-1398. doi: 10.1007/s00586-021-07051-4. Epub 2021 Nov 19.
Results Reference
derived
PubMed Identifier
32556585
Citation
Hermansen E, Austevoll IM, Hellum C, Storheim K, Myklebust TA, Aaen J, Banitalebi H, Anvar M, Rekeland F, Brox JI, Franssen E, Weber C, Solberg T, Haug KJ, Grundnes O, Brisby H, Indrekvam K. Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study. Eur Spine J. 2020 Sep;29(9):2254-2261. doi: 10.1007/s00586-020-06499-0. Epub 2020 Jun 18.
Results Reference
derived
PubMed Identifier
28327114
Citation
Hermansen E, Austevoll IM, Romild UK, Rekeland F, Solberg T, Storheim K, Grundnes O, Aaen J, Brox JI, Hellum C, Indrekvam K. Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study). BMC Musculoskelet Disord. 2017 Mar 21;18(1):121. doi: 10.1186/s12891-017-1491-7.
Results Reference
derived

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The NORDSTEN Studies/ The Spinal Stenosis Study

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