Active — Not RecruitingNot Applicable

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

France300 participantsStarted 2022-12-26

Plain-language summary

Osteosynthesis by pedicle screwing is the reference technique since the 1980s, due to the quality of the mechanical grip of the screw in the pedicle, despite difficulties of placing the implant in this narrow tunnel. This precision was improved by fluoroscopy, then by navigation, which made it possible to reduce the extra-pedicular placement of the screws and consequently the complications. Since the 2000s, robotic has been developed in all areas, including medicine and surgery, (Da Vinci robot in urology) and several robots are currently marketed for spinal surgery, Medtronic's Mazor X Stealth ™ robot being the most successful. The aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of complications, the clinical results and the medico-economic interest that robotic surgery can bring.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Evaluation of screw placement by a CT scan

Timeframe: one day

Trial details

NCT IDNCT05553028

SponsorElsan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-23