Actively Recruiting
Long-term Reoperations After Lumbar Spinal Stenosis Surgery
Led by University Hospital of North Norway · Updated on 2024-12-17
794
Participants Needed
1
Research Sites
971 weeks
Total Duration
On this page
Sponsors
U
University Hospital of North Norway
Lead Sponsor
T
The Royal Norwegian Ministry of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Reoperations After Lumbar Spinal Stenosis Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Operated between September 2007 and December 2015 with both 'Spinal stenosis' and 'Degenerative spondylolisthesis' labeled in the registry
- Underwent decompression surgery with or without additional fusion
You will not qualify if you...
- Operated using an anterior surgical approach
- Had a previous operation at the index spinal level
- Diagnosed with degenerative scoliosis
- Operated on more than 2 spinal levels
- Received non-instrumented fusion
- In the micro-decompression group, operated with standard laminectomy removing posterior midline structures or without magnifying devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University hospital of North Norway
Tromsø, Norway, 9038
Actively Recruiting
Research Team
E
Eirik Mikkelsen, MD
CONTACT
T
Tore Solberg, Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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