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NCT06024785
Vertebropexy - Randomized-controlled Trial
Conditions: Degeneration, Spinal Stenosis, Fusion of Spine
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 164
Sponsor: Balgrist University Hospital
Location: Balgrist University Hospital Zurich Canton of Zurich
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 technique (vertebropexy)
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06024785). StuddyBuddy aggregates publicly available trial information.