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Active (not recruiting) Not applicable NCT05553028

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

No applicable phase (e.g. observational)
Conditions: Osteosynthesis Mazor Robot Spinal Surgery Arthrosis; Spine

Sponsor: Elsan

trial.available_in: БГ
Overview
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
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.
Interventions
Computerised tomography
PROCEDURE
Locations 1
France (1)
Clinique Saint Martin
Pessac
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
26.12.2022
Completion date
01.01.2028
Registry ID
NCT05553028
Source
clinicaltrials.gov
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