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

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.

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Key information

Conditions

Osteosynthesis Arthritis Arthrosis; Spine Joint Diseases Mazor Robot Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Spinal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint Martin

Pessac, 33600, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computerised tomography

Procedure

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.

Primary outcomes

Evaluation of screw placement by a CT scan

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

Prospective Monocentric Randomized 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

Acronym: ROBARTHRODESE

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2028
First posted: Sep 23, 2022
Registry last updated: Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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