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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Balgrist University Hospital
RECRUITING
Zurich
Contact Information
Primary
Mazda Farshad, MD
Mazda.Farshad@balgrist.ch
+413861111
Backup
Sabrina Catanzaro, RN
Sabrina.Catanzaro@balgrist.ch
+413861111
Time Frame
Start Date: 2025-01-16
Estimated Completion Date: 2028-12
Participants
Target number of participants: 164
Treatments
Active_comparator: Indication for decompression, randomization for decompression
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
Experimental: Indication for decompression, randomization for vertebropexy
decompression (see above) and 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)
Active_comparator: Indication for fusion, randomization for fusion
decompression (see above) and posterolateral instrumented fusion (arthrodesis) with implantation of pedicle screws, titanium alloy rods across the level of listhesis, an intervertebral fusion device and local autograft as well as DBX (demineralized bone matrix) to improve bony fusion
Experimental: Indication for fusion, randomization for vertebropexy
decompression (see above) and 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)
Related Therapeutic Areas
Spinal Stenosis
Laminectomy
Sponsors
Leads: Balgrist University Hospital

This content was sourced from clinicaltrials.gov

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