The NORDSTEN Study - Degenerative Spondylolisthesis

NCT02051374 | Active Not Recruiting DMC

• 1 other identifier: 2013/366
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar Degenerative Spondylolisthesis (LDS) is a slippage of one vertebra over another caused by degeneration of facet joints, ligaments and intervertebral discs. Most patients suffer from symptoms related to spinal stenosis, such as radiating pain to the lower extremities, and typically increased pain in the lower limbs when walking upright and decreased when bending forward. There is a moderate grade of evidence for whether patients will achieve better outcome after surgery when decompression is followed by fusion. In theory, fusion following decompression should give more stability to the operated level, thus less pain and less progression of the olisthesis. On the other hand, fusion procedures, in general, are associated with more severe complications and postoperative mortality than decompression alone. In summary, there is still insufficient evidence for performing fusion in addition to decompression for patients with LDS. The investigators are planning a trial where the main aim is to detect whether the intervention-related difference in outcome between decompression alone (DA) and decompression followed by fusion with instrumentation (DF) is large enough to justify the use of the fusion procedure. The proposed trial is a randomized, controlled, multicentre, non- inferiority trial with two parallel groups, with 15 participating Norwegian hospitals. The main analysis will be performed 2 years after surgery with long-term follow-up planned at 5 and 10 years postoperatively.

Conditions

Lumbar Degenerative Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• The Oswestry Disability Index

  The Oswestry Disability Index (ODI) version 2.0 will be used as primary outcome measure. ODI is widely used by physicians treating patients with back-related symptoms and has been translated and validated for applications with Norwegian patients. It is a self-reported instrument comprising 10 sections where the patient is supposed to mark the most appropriate item. ODI scores range from 0 to 100, where 100 is the greatest impairment. The percentage change in ODI from baseline to follow- up will be computed. An individual cutoff value of 30% ODI- improvement will be used to dichotomize the patients in a success group and in a non- success group. This threshold value is estimated based on data from patients registered in the Norwegian registry for Spine Surgery The change in ODI from before operation to follow up will also be computed and reported as means.

  Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.

Secondary Outcomes (9)

• Zürich Claudication Questionnaire (ZCQ):

  Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.

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

  Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.

• Euroquol 5 dimensions questionnaire (EQ-5D)

  Prior to operation, 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.

• Global Perceived Effect (GPE) scale:

  3 months, 1 year, 2 years, 5 years and 10 years postoperatively.

• Percentages of participants with adverse effects (complications)

  During the hospital stay (average 2-3 days) and up to 10 years postoperatively.

Other Outcomes (1)

• Radiological findings

  MRI: Prior to operation. Skeletal x-rays:Prior to operation, at 3 month follow- up and at 2 year follow- up. CT scan: At 2 year follow- up.

Study Arms (2)

Decompression alone

ACTIVE COMPARATOR

Posterior approach with decompression will be performed. The decompression will be done after microsurgical principles, and the midline structures will be preserved. The surgeons will either use microscope or magnifying glasses.

Procedure: Decompression alone

Decompression followed by fusion with instrumentation

ACTIVE COMPARATOR

Posterior approach with decompression will be performed, followed by posterolateral pedicle screw fixation with or without an additional cage. The surgeons will either use microscope or magnifying glasses.

Procedure: Decompression followed by fusion with instrumentation

Interventions

Decompression alone PROCEDURE

Decompression alone

Decompression followed by fusion with instrumentation PROCEDURE

Decompression followed by fusion with instrumentation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years of age
• do understand Norwegian language, spoken and in writing
• have a degenerative lumbar spondylolisthesis, with a slip \>=3 mm, verified on standing plain x-rays in lateral view
• have a spinal stenosis in the level of spondylolisthesis, shown on MRI
• have clinical symptoms of spinal stenosis as neurogenic claudication or radiating pain into the lower limbs, not responding to at least 3 months of qualified conservative treatment
• are able to give informed consent and to respond to the questionnaires.

You may not qualify if:

• are not willing to give written consent
• are participating in another clinical trial that may interfere with this trial
• are ASA- classified \> 3
• are older than 80 years
• are not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical)
• have cauda equina syndrome (bowel or bladder dysfunction) or fixed complete motor deficit
• have a slip \>=3 mm in more than one level
• have an isthmic defect in pars interarticularis
• have a fracture or former fusion of the thoracolumbal region
• have had previous surgery in the level of spondylolisthesis
• have a lumbosacral scoliosis more than 20 degrees verified on AP-view
• have distinct symptoms in one or both legs due to other diseases, e.g. polyneuropathy, vascular claudication or osteoarthritis
• have radicular pain due to a MRI verified foraminal stenosis in the slipped level, with deformation of the nerve root because of a bony narrowing in the vertical direction

Sponsors & Collaborators

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

Study Sites (1)

Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital

Bergen, Hagevik, 5217, Norway

Location

Related Publications (6)

• 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

• Kgomotso EL, Hellum C, Fagerland MW, Solberg T, Brox JI, Storheim K, Hermansen E, Franssen E, Weber C, Brisby H, Algaard KRH, Furunes H, Banitalebi H, Ljostad I, Indrekvam K, Austevoll IM; Nordsten collaborators. Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial. BMJ. 2024 Aug 7;386:e079771. doi: 10.1136/bmj-2024-079771.

  PMID: 39111800 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

• Hellum C, Rekeland F, Smastuen MC, Solberg T, Hermansen E, Storheim K, Brox JI, Furunes H, Franssen E, Weber C, Brisby H, Grundnes O, Algaard KRH, Boker T, Banitalebi H, Indrekvam K, Austevoll IM. Surgery in degenerative spondylolisthesis: does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial). Spine J. 2023 Nov;23(11):1613-1622. doi: 10.1016/j.spinee.2023.06.386. Epub 2023 Jun 22.

  PMID: 37355044 DERIVED

• Austevoll IM, Hermansen E, Fagerland MW, Storheim K, Brox JI, Solberg T, Rekeland F, Franssen E, Weber C, Brisby H, Grundnes O, Algaard KRH, Boker T, Banitalebi H, Indrekvam K, Hellum C; NORDSTEN-DS Investigators. Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis. N Engl J Med. 2021 Aug 5;385(6):526-538. doi: 10.1056/NEJMoa2100990.

  PMID: 34347953 DERIVED

• Austevoll IM, Hermansen E, Fagerland M, Rekeland F, Solberg T, Storheim K, Brox JI, Lonne G, Indrekvam K, Aaen J, Grundnes O, Hellum C. Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2019 Jan 5;20(1):7. doi: 10.1186/s12891-018-2384-0.

  PMID: 30611229 DERIVED

MeSH Terms

Interventions

Decompression

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena

Study Officials

• Christian Hellum, MD, PhD

  Orthopeadic Clinic, Oslo University Hospital

  STUDY CHAIR

• Ivar Magne Austevoll, Md, PhD

  Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Eric Loratang Kgomotso, MD

  Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

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: January 10, 2014
• First Posted: January 31, 2014
• Study Start: February 1, 2014
• Primary Completion: February 10, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 6, 2025

Record last verified: 2025-01

Locations

NO (1)