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
Sponsors and collaborators
University Hospital of North Norway
Lead sponsor
The Royal Norwegian Ministry of Health
Collaborator
Haukeland University Hospital
Collaborator