The NORDSTEN Studies/The Observational Cohort Study

NCT03562936 | Active Not Recruiting DMC

• 1 other identifier: 2011/2034-2
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

The NORDSTEN- OS(Observational study) aim to study the natural course in patients with mild to moderate symptomatic lumbar spinal stenosis with and without degenerative spondylolisthesis. 10 years follow-up is planned. The NORDSTEN-OS is one of three studies in The NORwegian Degenerative Spondylolisthesis and Spinal STENosis studies. The two other studies are: NORDSTEN-SST (Spinal stenosis trial) (NCT02007083); a randomized controlled trial comparing the clinical and radiological results in three different decompression techniques in patients with lumbar spinal stenosis. The NORDSTEN-DS (Degenerative spondylolisthesis) (NCT02051374); a randomized controlled trial comparing the outcome of surgery with decompression without fixation and decompression with fixation in patients with lumbar spinal stenosis and concurrent degenerative spondylolisthesis.

Conditions

Degenerative Lumbar Spinal Stenosis; Degenerative Spondylolisthesis

Keywords

LSS,DS

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI) version 2.0

  ODI is a patient reported outcome measure (PROM) comprising 10 sections where the patient is supposed to mark the most appropriate item. ODI scores range from 0 to 100, with higher score indicating more severe pain and disability. ODI is recommended by international expert panels for the evaluation of disability in clinical trials and commonly used by physicians treating patients with back-related symptoms. It has been translated and validated for applications with Norwegian patients. The change in ODI from baseline to follow-up will be registered.

  Baseline and follow-up at 2,5 and 10 years

Secondary Outcomes (6)

• Zürich Claudication Questionnaire (ZCQ)

  Baseline and follow-up at 2,5 and 10 years

• Numeric Rating Scale (NRS) for back and leg pain.

  Baseline. Follow-up at 2,5 and 10 years

• EuroQol 5 dimensions questionnaire (EQ-5D).

  Baseline and follow-up at 2,5 and 10 years

• Time from inclusion until time for to surgery.

  10 years

• A questionnaire mapping subjective change of symptoms from baseline in a 6 point response scale, ranging from completely recovered to getting worse.

  Follow-up at 2,5 and 10 years

Eligibility Criteria

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

Study Population

All patients with symptomatic LSS with and without LDS referred to the participating orthopedic- or neurosurgical departments will be eligible for inclusion in the observational cohort. The burden of symptoms is considered not to be severe enough to opt for surgical treatment, and this conclusion is made through informed shared decision-making between surgeon and patient. Patients will be given verbal and written information about this observational study. If willing to participate, the patients sign an informed consent. The treatment of these patients will be pragmatic "usual care". There will not be any planned specific conservative treatment, but the surgeon can recommend specific conservative treatments in any case if preferred

You may qualify if:

• Presence of clinical symptoms of spinal stenosis. Neurogenic claudication or radiating pain to one or both lower limbs
• Radiological findings corresponding to the clinical symptoms of LSS. Central stenosis or lateral recess stenosis with or without degenerative spondylolisthesis
• Able to understand Norwegian language, both spoken and written
• Able to give informed consent and to answer the questionnaires
• Over 18 years of age

You may not qualify if:

• Not willing to give written consent
• Participation in other clinical trial that may interfere with this trial
• American Society of Anesthesiologists (ASA) 4 or 5
• Age older than 80 years
• Not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physically)
• Presence of cauda equina syndrome (bowel and bladder dysfunction) or complete motor deficit
• Presence of an isthmic defect in pars interarticularis
• Former fracture of the thoracolumbar region
• Previous surgery in the lumbar region
• Distinct symptoms in one or both legs due to other diseases, e.g. polyneuropathy, vascular claudication or osteoarthritis
• Lumbosacral scoliosis of more than 20 degrees verified on standing x-ray AP-view

Sponsors & Collaborators

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

Study Sites (1)

Kysthospitalet i Hagavik, Orthopeadic clinic, Haukeland University Hospital

Hagavik, 5217, Norway

Location

Related Publications (2)

• 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

• 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

Study Officials

• Frode G Rekeland, MD

  Kysthospitalet i Hagavik, Orthopeadic clinic, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Clemens Weber, PhD, MD

  Stavanger University Hospital, Department for Neurosurgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 20, 2018
• Study Start: February 1, 2014
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

NO (1)