Long-term Reoperations After Lumbar Spinal Stenosis Surgery

Recruiting now

Conditions studied: Degenerative Lumbar Spondylolisthesis

In brief

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.

Key facts

Study ID

NCT06407063

Run by

University Hospital of North Norway

People needed

794

Starts

2007-09-19

Expected to finish

2026-04-30

Last updated by the study team

2024-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University hospital of North Norway — Tromsø, Norway (enrolling)

Full record on ClinicalTrials.gov

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