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Активно (без набиране) Не е приложимо 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

Не е приложима фаза (напр. обсервационно)
Заболявания: Osteosynthesis Mazor Robot Spinal Surgery Arthrosis; Spine

Спонсор: Elsan

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
Computerised tomography
PROCEDURE
Места на провеждане 1
Франция (1)
Clinique Saint Martin
Pessac
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
26.12.2022
Крайна дата
01.01.2028
Регистрационен номер
NCT05553028
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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