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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06024785). StuddyBuddy aggregates publicly available trial information.