Assessing vertebropexy for spinal stabilization in degenerative lumbar conditions
Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
This study tests if a new procedure called vertebropexy can help people with degenerative lower back conditions feel better and avoid more surgeries compared to traditional spinal fusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Balgrist University Hospital Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06024785 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of vertebropexy, a ligamentous fixation technique, compared to traditional spinal fusion surgery in patients with degenerative lumbar spinal disease. The study aims to determine whether vertebropexy can reduce the need for additional fusion surgeries and the associated risks of revision surgeries. Participants will be monitored for outcomes related to spinal stability and pain relief. The trial focuses on patients requiring decompression and fusion surgeries due to spinal canal stenosis and degenerative listhesis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific indications for lumbar decompression and fusion surgery due to spinal stenosis and degenerative listhesis.
Not a fit: Patients with conditions such as disc herniation, fractures, or those requiring revision surgery for infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive alternative to spinal fusion, reducing the risk of complications and the need for revision surgeries.
How similar studies have performed: While vertebropexy is a newer technique, similar studies on ligamentous fixation have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zurich
- Balgrist University Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Mazda Farshad, MD
- Email: Mazda.Farshad@balgrist.ch
- Phone: +413861111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.