Clinical trial NCT02007083: The NORDSTEN Studies/ The Spinal Stenosis Study
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar Spinal stenosis
Surgical treatment of LSS.
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Møre og Romsdal Hospital Trust
First posted: 2013-12-10
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 2, 5 and 10 years after surgery
Secondary outcomes:
measure: Zurich claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery.
timeFrame: 2, 5 and 10 years after surgery
Other outcomes:
measure: Dural Sac Cross sectional Area (DSCSA)
timeFrame: 3 months after surgery
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hagevik
Study officials:
affiliation: The Coastal Hospital of Hagevik, Orthopeadic Clinic, Haukeland University City
name: Kari Indrekvam Indrekvam, MD, Dr Med
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.