Vertebropexy - Randomized-controlled Trial
Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
Balgrist University Hospital
164 participants
Jan 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria7
- 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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Interventions
microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side. Additional stabilization of the spine with a ligament (for instance semitendinosus donor allograft), which connect the postoprior structures (Proc. Spinosus and/or Lamina) of the vertebrae . Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia)
Locations(1)
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NCT06024785