Clinical Trial

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

Study acronym: ROBARTHRODESE

Active, Not Recruiting

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2022-09-22; most recent amendment 2026-04-20.

Status change: Recruiting → Active, Not Recruiting 2026-04-20

Status change: Not Yet Recruiting → Recruiting 2023-02-20

Trial Details

NCT Number	NCT05553028
Lead Sponsor	Elsan
Conditions	Osteosynthesis, Mazor Robot, Spinal Surgery, Arthrosis; Spine
Enrollment	300 participants
Start Date	2022-12-26
Primary Completion	2026-01-23 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-21