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RECRUITING
NCT06024785
NA

Vertebropexy - Randomized-controlled Trial

Sponsor: Balgrist University Hospital

View on ClinicalTrials.gov

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)

Official title: Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2025-01-16

Completion Date

2028-12

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

PROCEDURE

Vertebropexy

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)

Balgrist University Hospital

Zurich, Switzerland