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 (ROBARTHRODESE)

Elsan

Status: Enrolling

Conditions: Spinal Surgery; Osteosynthesis; Mazor Robot; Arthrosis; Spine

Treatments: Procedure: Computerised tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT05553028

2022-A00874-39

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Robot assisted surgery

Experimental group

Description:

Patient operated for thoracic and/or lumbar spine arthrodesis with robot assistance Mazor

Treatment:

Procedure: Computerised tomography

Conventional surgery

Active Comparator group

Description:

Patient operated for thoracic and/or lumbar spine arthrodesis with conventional surgery

Treatment:

Procedure: Computerised tomography