Vertebropexy - Randomized-controlled Trial

Launched by BALGRIST UNIVERSITY HOSPITAL · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial, called Vertebropexy, is looking at how well a new treatment works for patients with certain back problems, specifically those involving the lower spine. The study aims to compare the need for additional surgery to fuse the spine with the potential risks of needing another surgery later on. It focuses on patients who have issues like spinal stenosis (narrowing of the spinal canal) and degeneration of the spine, and it will evaluate a technique called vertebropexy, which helps stabilize the spine.

To participate in the trial, you need to be at least 18 years old and require surgery for one or two levels of your lower spine. You must have specific conditions that make you a candidate for either decompression surgery (to relieve pressure) or fusion surgery (to stabilize the spine). Participants should be able to understand German, as the study will be conducted in that language. If you join the trial, you will be monitored for your recovery and any complications over several weeks after the procedure. This study is currently recruiting participants, and it's important to note that some individuals with certain medical conditions or previous surgeries may not be eligible.

Gender

ALL

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