Long-term Reoperations After Lumbar Spinal Stenosis Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of North Norway

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Micro-decompression alone
  • Decompression and instrumented fusion

Treatment groups

794 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital of North Norway

Lead sponsor

The Royal Norwegian Ministry of Health

Collaborator

Haukeland University Hospital

Collaborator