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

Not Applicable

Recruiting

• Conditions: Spinal Surgery; Arthrosis; Spine; Osteosynthesis; Mazor Robot
• Interventions: Procedure: Computerised tomography

• Registration Number: NCT05553028
• Lead Sponsor: Elsan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-23
• Study Start: 2022-12-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2025-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot assisted surgery	Computerised tomography	Patient operated for thoracic and/or lumbar spine arthrodesis with robot assistance Mazor
Conventional surgery	Computerised tomography	Patient operated for thoracic and/or lumbar spine arthrodesis with conventional surgery

Primary Outcome Measures

Name	Time	Method
Evaluation of screw placement by a CT scan	one day	Screws placement will be evaluated for each patient by a CT scan on D1 post-intervention. The evaluation of the placement of the screws (reading of the CT images) will be carried out by 2 radiologists independent of the surgical team, blinded to the technique used for the placement of the screws (robot-assisted/conventional surgery). In case of disagreement between the 2 evaluators, a 3rd evaluator will be requested.

Trial Locations

Locations (1)

Clinique Saint Martin; 🇫🇷 Pessac, France