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Long-term Reoperations After Lumbar Spinal Stenosis Surgery

NCT06407063 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 794

Last updated 2024-12-17

No results posted yet for this study

Summary

Severe and persisting pain and disability due to a degenerative narrowing of the spinal canal, lumbar spinal stenosis, can be operated with a simple surgical decompression. Sometimes, there is also a slippage of vertebra, degenerative spondylolisthesis. In such cases, instrumental stabilization (e.g. screws and rods) has been recommended. Even though additional fusion is more complex and riskier, and evidence in high-quality Scandinavian studies shows that it is unnecessary, decompression plus fusion is still the treatment of choice in the USA and most European countries. This reluctance to change clinical practice is mainly due to concerns about long-term results, especially higher reoperation rates among patients operated with decompression only. This register-based non-inferiority study aims to assess long-term reoperations among those treated with and without additional fusion surgery.

Conditions

  • Degenerative Lumbar Spondylolisthesis

Interventions

PROCEDURE

Micro-decompression alone

In surgical treatment of Degenerative Spondylolisthesis patients are operated on with a midline-preserving decompression without fusion

PROCEDURE

Decompression and instrumented fusion

In surgical treatment of Degenerative Spondylolisthesis patients are operated on with a decompression followed by an instrumental fusion with or without an additional cage

Sponsors & Collaborators

  • The Royal Norwegian Ministry of Health

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Tore Solberg, Prof · University Hospital of North Norway

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-19
Primary Completion
2024-12-11
Completion
2026-04-30

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 NCT06407063 on ClinicalTrials.gov