The NORDSTEN Studies/ The Spinal Stenosis Study

NCT02007083 | Active Not Recruiting DMC

• 1 other identifier: 2011/2034
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar Spinal stenosis; Surgical treatment of LSS.

Outcome Measures

Primary Outcomes (1)

• 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.

  2, 5 and 10 years after surgery

Secondary Outcomes (1)

• Zurich claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery.

  2, 5 and 10 years after surgery

Other Outcomes (1)

• Dural Sac Cross sectional Area (DSCSA)

  3 months after surgery

Study Arms (3)

Bilateral laminotomy (BL)

ACTIVE COMPARATOR

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)

Unilateral laminotomy with crossover (UL)

ACTIVE COMPARATOR

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)

Spinous process osteotomy (SPO)

ACTIVE COMPARATOR

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)

Interventions

Bilateral laminotomy (BL) PROCEDURE

Also known as: Fenestration procedures., Multiple laminotomies.

Bilateral laminotomy (BL)

Unilateral laminotomy with crossover (UL) PROCEDURE

Also known as: microdecompression.

Unilateral laminotomy with crossover (UL)

Spinous Process Osteotomy (SPO) PROCEDURE

Also known as: Laminarthrectomi., Micro Spinous Process Osteotomy

Spinous process osteotomy (SPO)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Møre og Romsdal Hospital Trust: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Hagevik, 5217, Norway

Location

Related Publications (8)

• Indrekvam K, Myklebust TA, Austevoll IM, Hermansen E, Banitalebi H, Banerud IF, Weber C, Brisby H, Brox JI, Hellum C, Storheim K. Responsiveness of the Oswestry Disability Index and Zurich Claudication Questionnaire in patients with lumbar spinal stenosis: evaluation of surgically treated patients from the NORDSTEN study. Eur Spine J. 2024 Nov;33(11):4270-4280. doi: 10.1007/s00586-024-08440-1. Epub 2024 Aug 13.

  PMID: 39134699 DERIVED

• Aaen J, Banitalebi H, Austevoll IM, Hellum C, Storheim K, Myklebust TA, Anvar M, Weber C, Solberg T, Grundnes O, Brisby H, Indrekvam K, Hermansen E. Is the presence of foraminal stenosis associated with outcome in lumbar spinal stenosis patients treated with posterior microsurgical decompression. Acta Neurochir (Wien). 2023 Aug;165(8):2121-2129. doi: 10.1007/s00701-023-05693-5. Epub 2023 Jul 5.

  PMID: 37407851 DERIVED

• Indrekvam K, Banerud IF, Hermansen E, Austevoll IM, Rekeland F, Guddal MH, Solberg TK, Brox JI, Hellum C, Storheim K. The Norwegian degenerative spondylolisthesis and spinal stenosis (NORDSTEN) study: study overview, organization structure and study population. Eur Spine J. 2023 Dec;32(12):4162-4173. doi: 10.1007/s00586-023-07827-w. Epub 2023 Jul 3.

  PMID: 37395780 DERIVED

• 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.

  PMID: 35344046 DERIVED

• 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.

  PMID: 35033042 DERIVED

• 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.

  PMID: 34797405 DERIVED

• 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.

  PMID: 32556585 DERIVED

• 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.

  PMID: 28327114 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Crossing Over, Genetic

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Homologous Recombination; Recombination, Genetic; Genetic Phenomena

Study Officials

• Kari Indrekvam Indrekvam, MD, Dr Med

  The Coastal Hospital of Hagevik, Orthopeadic Clinic, Haukeland University City

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2013
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

NO (1)