Long-term Frequency of Reoperations After Micro-decompression Alone Versus Decompression and Instrumented Fusion in Patients With Lumbar Spinal Stenosis and Degenerative Spondylolisthesis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
University hospital of North Norway
RECRUITING
Tromsø
Contact Information
Primary
Eirik Mikkelsen, MD
eirik.mikkelsen@unn.no
Backup
Tore Solberg, Prof
Tore.Solberg@unn.no
+47 91364531
Time Frame
Start Date: 2007-09-19
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 794
Treatments
Patients treated for Degenerative Spondylolisthesis
Patients operated for Degenerative Spondylolisthesis with Lumbar Spinal Stenosis
Related Therapeutic Areas
Sponsors
Collaborators: The Royal Norwegian Ministry of Health, Haukeland University Hospital
Leads: University Hospital of North Norway

This content was sourced from clinicaltrials.gov

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