NCT06407063 Long-term Reoperations After Lumbar Spinal Stenosis Surgery
| NCT ID | NCT06407063 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of North Norway |
| Condition | Degenerative Lumbar Spondylolisthesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 794 participants |
| Start Date | 2007-09-19 |
| Primary Completion | 2024-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 794 participants in total. It began in 2007-09-19 with a primary completion date of 2024-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Eirik Mikkelsen, MD
✉ eirik.mikkelsen@unn.noTore Solberg, Prof
PRINCIPAL INVESTIGATOR
University Hospital of North Norway
Frequently Asked Questions
Who can join the NCT06407063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Lumbar Spondylolisthesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06407063 currently recruiting?
Yes, NCT06407063 is actively recruiting participants. Contact the research team at eirik.mikkelsen@unn.no for enrollment information.
Where is the NCT06407063 trial being conducted?
This trial is being conducted at Tromsø, Norway.
Who is sponsoring the NCT06407063 clinical trial?
NCT06407063 is sponsored by University Hospital of North Norway. The principal investigator is Tore Solberg, Prof at University Hospital of North Norway. The trial plans to enroll 794 participants.