Comparing robotic and conventional surgery for spine fusion
Prospective Monocentric Randomized Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery
This study is testing whether robotic surgery for spine fusion works better and has fewer complications than traditional surgery for people with spine problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 1 site (Pessac) |
| Trial ID | NCT05553028 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a robotic-assisted surgery technique for thoracic and lumbar spine arthrodesis compared to traditional surgical methods. It focuses on the precision of screw placement, the occurrence of complications, and the overall clinical outcomes associated with each approach. By utilizing the Mazor X Stealth™ robot, the study aims to enhance surgical accuracy and reduce risks associated with spinal surgery. Participants will be randomly assigned to either the robotic or conventional surgery group to assess the differences in outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who require thoracic or lumbar spine arthrodesis due to various spinal conditions.
Not a fit: Patients with a BMI of 40 kg/m² or higher, those with a history of instrumented lumbar surgery, or those with psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing spine fusion.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries in various fields, suggesting potential success for this approach in spinal surgery as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male, female, over 18 years old, * Any patient operated for thoracic and/or lumbar spine arthrodesis (spondylolisthesis, asymmetric disc disease, spinal instability, spinal deformities, advanced disc disease), * Patient having given his free, informed and written consent to participate in the study, * Patient able to answer questionnaires, able to communicate in the language of the country of the study, * Negative pregnancy test, * Patient affiliated to a social security scheme or beneficiary of such a scheme. Exclusion Criteria: * Minor, * Psychological disorders, * Addiction to analgesics, * Chronic infection, * History of instrumented lumbar surgery, * BMI greater than or equal to 40kg/m², * Pregnant or breastfeeding woman, * Patient participating in another clinical study, * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
Where this trial is running
Pessac
- Clinique Saint Martin — Pessac, France (Recruiting)
Study contacts
- Study coordinator: Nicolas AUROUER, Dr
- Email: nicolas.aurouer@gmail.com
- Phone: 06 21 98 82 44
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.