RecruitingNCT06407063

Long-term Reoperations After Lumbar Spinal Stenosis Surgery

Long-term Frequency of Reoperations After Micro-decompression Alone Versus Decompression and Instrumented Fusion in Patients With Lumbar Spinal Stenosis and Degenerative Spondylolisthesis


Sponsor

University Hospital of North Norway

Enrollment

794 participants

Start Date

Sep 19, 2007

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • operated between September 2007 and December 2015 labeled in the registry with both 'Spinal stenosis' and 'Degenerative spondylolisthesis'
  • operated on with decompression with or without an additional fusion

Exclusion Criteria6

  • operated with an anterior approach
  • had a former operation at index Level
  • was labeled with a degenerative scoliosis
  • was operated in more than 2 Levels
  • was operated with non-instrumented fusion
  • operated with a standard laminectomy with removing of the posterior midline structures or operated without magnifying devices was excluded from the micro-decompression group

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREMicro-decompression alone

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

PROCEDUREDecompression 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


Locations(1)

University hospital of North Norway

Tromsø, Norway

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06407063


Related Trials