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The NORDSTEN Study - Degenerative Spondylolisthesis

NCT02051374 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2025-02-06

No results posted yet for this study

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

Interventions

PROCEDURE

Decompression alone

PROCEDURE

Decompression followed by fusion with instrumentation

Sponsors & Collaborators

  • Møre og Romsdal Hospital Trust

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Christian Hellum, MD, PhD · Orthopeadic Clinic, Oslo University Hospital

  • Ivar Magne Austevoll, Md, PhD · Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital

  • Eric Loratang Kgomotso, MD · Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2023-02-10
Completion
2028-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02051374 on ClinicalTrials.gov