Vertebropexy - Randomized-controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBalgrist University Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vertebropexy
Treatment groups
164 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov