Assessing long-term reoperations after lumbar spinal stenosis surgery
Official title: Long-term Frequency of Reoperations After Micro-decompression Alone Versus Decompression and Instrumented Fusion in Patients With Lumbar Spinal Stenosis and Degenerative Spondylolisthesis
Run by University Hospital of North Norway · NCT06407063 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 794 (estimated) |
| Sponsor | University Hospital of North Norway Academic / other |
| Locations | 1 site (Tromsø) |
| Status | Recruiting |
| Started | September 19, 2007 |
| Main results expected | December 11, 2024 |
| Study ends | April 30, 2026 |
| Registry record updated | December 17, 2024 |
| Trial ID | NCT06407063 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who underwent surgery for spinal stenosis and degenerative spondylolisthesis between September 2007 and December 2015.
✕Probably not a fit
Patients who had previous surgeries at the same level or those with degenerative scoliosis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-term safety evaluation of NVDX3 treatment
This study is testing the long-term safety of the NVDX3 treatment in patients who have already received it, by checking in with them every year for 10 years to see if they experience any problems.
-
Remote-controlled CT to speed stroke thrombolysis in rural areas
This project tests whether remote-controlled CT scans with live audio–video guidance from a hospital stroke team can shorten time to intravenous thrombolysis for people with suspected acute ischemic stroke in rural Northern Norway.
-
Atrial fibrillation screening for people with higher-than-median NT-proBNP in Tromsø
This will test whether giving 7-day wearable ECG monitoring to people aged 40+ with NT-proBNP above the median can find atrial fibrillation and reduce ischemic stroke and vascular deaths compared with no long-term monitoring.
-
Faecal microbiota transplantation to change gut flora in people with Alzheimer's disease
This pilot tests whether a donor stool transplant given during a colonoscopy is safe and feasible for people with mild-to-moderate Alzheimer's disease.
-
Virtual biopsy for prostate cancer using PSMA PET and AI
This project will try to use PSMA PET scans combined with machine learning to predict Gleason scores without invasive biopsies for men with suspected or diagnosed prostate cancer.
-
6-month dietitian-guided nutrition program for patients recovering from critical illness
This project will try giving ICU patients individualized nutrition care from a clinical dietitian during their hospital stay and for six months after to see if they consume more calories and protein than with usual care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.