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RECRUITING
NCT06407063

Long-term Reoperations After Lumbar Spinal Stenosis Surgery

Sponsor: University Hospital of North Norway

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

794

Start Date

2007-09-19

Completion Date

2026-04-30

Last Updated

2024-12-17

Healthy Volunteers

No

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

Locations (1)

University hospital of North Norway

Tromsø, Norway