Status:
RECRUITING
Vertebropexy - Randomized-controlled Trial
Lead Sponsor:
Balgrist University Hospital
Conditions:
Degeneration
Spinal Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation t...
Detailed Description
The global share of people over the age of 65 years has been consistently on the rise over the past few decades, and is still projected to increase. The increasing life expectancy, overall advances in...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥ 18 years
- Single-level or two-level lumbar surgery needed
- Indication for decompression surgery in patients with spinal canal stenosis and additional stable degenerative listhesis (without facet joint effusion ≥ 2mm)
- Indication for fusion surgery in patients with spinal canal stenosis and additional unstable degenerative listhesis (facet joint effusion ≥ 2mm), in patients with foraminal stenosis and additional degenerative listhesis, and in patients with segment degeneration of the disc
- Understanding in German language
- Exclusion criteria:
- Indication for decompression and/or fusion surgery in patients with solely disc herniation, fractures, lytic listhesis, tumor
- Patients undergoing revision surgery for infection
- Patients undergoing revision surgery on the same level if bony structures have been removed (e.g. prior laminectomy or midline decompression)
- Patients undergoing revision surgery in case of prior fusion surgery
- Inability to understand the study for linguistic or cognitive reasons
- Anticipated clinical follow-up of less than 6 weeks after inclusion
- Participation in other clinical trials
Exclusion
Key Trial Info
Start Date :
January 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06024785
Start Date
January 16 2025
End Date
December 1 2028
Last Update
February 13 2025
Active Locations (1)
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1
Balgrist University Hospital
Zurich, Switzerland, 8008