Assessing long-term reoperations after lumbar spinal stenosis surgery
Long-term Frequency of Reoperations After Micro-decompression Alone Versus Decompression and Instrumented Fusion in Patients With Lumbar Spinal Stenosis and Degenerative Spondylolisthesis
This study is trying to see if patients who had surgery for back problems need fewer follow-up surgeries if they only had decompression compared to those who also had fusion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 794 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of North Norway Academic / other |
| Locations | 1 site (Tromsø) |
| Trial ID | NCT06407063 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term reoperation rates in patients who underwent surgery for degenerative lumbar spondylolisthesis with either micro-decompression alone or decompression combined with instrumented fusion. The research aims to clarify the ongoing debate regarding the necessity of additional fusion procedures, which are often deemed more complex and risky. By analyzing registry data from surgeries performed between 2007 and 2015, the study seeks to determine if decompression alone is non-inferior to the combined approach in terms of clinical outcomes and reoperation rates. The findings could challenge current surgical practices that favor fusion despite evidence suggesting it may not provide additional benefits.
Who should consider this trial
Good fit: Ideal candidates are individuals who underwent surgery for spinal stenosis and degenerative spondylolisthesis between September 2007 and December 2015.
Not a fit: Patients who had previous surgeries at the same level or those with degenerative scoliosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a shift in surgical practices, potentially reducing unnecessary surgeries and associated risks for patients.
How similar studies have performed: Previous studies, particularly from Scandinavian registries, have shown promising results supporting the efficacy of decompression alone, indicating that this approach is not novel but rather a continuation of ongoing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Tromsø
- University hospital of North Norway — Tromsø, Norway (Recruiting)
Study contacts
- Principal investigator: Tore Solberg, Prof — University Hospital of North Norway
- Study coordinator: Eirik Mikkelsen, MD
- Email: eirik.mikkelsen@unn.no
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.