The NORDSTEN Study - Degenerative Spondylolisthesis (NORDSTEN/DS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Haukeland University Hospital
Sponsor:
Collaborator:
Møre and Romsdal Hospital Trust.
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT02051374
First received: January 10, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Lumbar Degenerative Spondylolisthesis
Procedure: Decompression alone
Procedure: Decompression followed by fusion with instrumentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Degenerative Lumbar Spondylolisthesis: Is Only Decompression Good Enough? A Prospective Randomized Clinical Multi- Institutional Trial

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • The Oswestry Disability Index [ Time Frame: Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively. ] [ Designated as safety issue: No ]

    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 change in ODI from baseline to follow- up will be computed. An individual cutoff value for ODI- improvement will be used to dichotomize the patients in a success group and in a non- success group. This threshold value is planned to be 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.



Secondary Outcome Measures:
  • Zürich Claudication Questionnaire (ZCQ): [ Time Frame: Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively. ] [ Designated as safety issue: No ]

    Zürich Claudication Questionnaire is also known as the Swiss Spinal Stenosis Questionaire, and is a self-completed disorder-specific functional score consisting of three domains: symptom severity, physical function and patient satisfaction. The questionnaire is translated and validated for use on Norwegian patients suffering from degenerative lumbar spinal stenosis.

    The change in ZCQ from baseline to follow- up will be computed. An individual cutoff value will be used to dichotomize the patients in a success group and in a non- success group.


  • Numeric Rating Scale (NRS) for back- and leg pain [ Time Frame: Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively. ] [ Designated as safety issue: No ]
    NRS is a PRO that assesses self-reported pain the patients experienced in the last week from 0 (no pain) to 10 (the worst pain imaginable), on a horizontal 10 centimeter scale. The change in NRS from baseline to follow- up will be computed separately for leg and back pain.

  • Euroquol 5 dimensions questionnaire (EQ-5D) [ Time Frame: Prior to operation, 3 months, 1 year, 2 years, 5 years and 10 years postoperatively. ] [ Designated as safety issue: No ]
    EQ-5D is a generic PRO that is self-completed and comprises 5 questions relating to mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. It is one of the most frequent used questionnaires in determining cost- effectiveness in health economic evaluation. We will consider doing such an evaluation as part of the secondary outcome analysis.

  • Global Perceived Effect (GPE) scale: [ Time Frame: 3 months, 1 year, 2 years, 5 years and 10 years postoperatively. ] [ Designated as safety issue: No ]
    Patient- rated satisfaction with treatment and treatment outcome will be assessed using single question with seven-point descriptive scaling.

  • Number of participants with adverse effects (complications) [ Time Frame: During the hospital stay (average 2-3 days) and up to 10 years postoperatively. ] [ Designated as safety issue: No ]
    A research coordinator will record complications consecutively during the hospital stay. These may include infections, hematoma, neurological deficits due to the operation, CSF leakage and other major adverse effects. Later complications such as wound infections and hardware failure, will be recorded by the self- questionnaires.

  • Number of participants needing a reoperation. [ Time Frame: From operation time and up to 10 years. ] [ Designated as safety issue: No ]
    Any new operation in the primary operated level during the follow- up period will be recorded as a reoperation.


Other Outcome Measures:
  • Radiological findings [ Time Frame: MRI and X-rays: Prior to operation. CT scan: At 2 years follow- up ] [ Designated as safety issue: Yes ]

    The following radiological procedures will be performed:

    1. MRI of the lumbar spine, including T1 and T2 sequences in the axial and sagittal plane.
    2. Skeletal x-rays:

      • Standard images; frontal and lateral view of L1 to S1 in standing position.
      • Ex/flex- images; lateral view of L1 to S1 with respectively maximal flexion and maximal extension
    3. CT scan: To compute the fusion rate. "Union" is classified as bony continuity between the fused vertebrae in both the coronal and sagittal view.


Estimated Enrollment: 256
Study Start Date: January 2014
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Decompression alone
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
Active Comparator: Decompression followed by fusion with instrumentation
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • have ODI- score 25 points or more
  • are able to give informed consent and to respond to the questionnaires.

Exclusion Criteria:

  • 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 precedures (psychosocially, mentally and physical)
  • have cauda equina syndrom (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051374

Contacts
Contact: Ivar Magne Austevoll, MD +4756565800 ivar.magne.austevoll@helse-bergen.no
Contact: Christian Hellum, MD, PhD +47 02770 christian.hellum@medisin.uio.no

Locations
Norway
Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital Not yet recruiting
Bergen, Hagevik, Norway, 5217
Contact: Ivar Magne Austevoll, MD    +47 56565800    ivar.magne.austevoll@helse-bergen.no   
Contact: Kari Indrekvam, MD, Dr.Med    +4756565800    kari.indrekvam@helse-bergen.no   
Principal Investigator: Ivar Magne Austevoll, MD         
Sponsors and Collaborators
Haukeland University Hospital
Møre and Romsdal Hospital Trust.
Investigators
Study Chair: Christian Hellum, MD, PhD Orthopeadic Clinic, Oslo University Hospital
Principal Investigator: Ivar Magne Austevoll, Md Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02051374     History of Changes
Other Study ID Numbers: 2013/366, 2013/366
Study First Received: January 10, 2014
Last Updated: January 29, 2014
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014