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

Spinal Surgery Clinical Trial

— ROBARTHRODESE  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553028
• Other study ID #: 2022-A00874-39
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2022
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: Elsan
• Contact: Nicolas AUROUER, Dr
• Phone: 06 21 98 82 44
• Email: nicolas.aurouer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthrosis; Spine
• Osteoarthritis
• Osteosynthesis
• Spinal Surgery

Intervention

Procedure:
• Computerised tomography
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.

Locations

Country	Name	City	State
France	Clinique Saint Martin	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of screw placement by a CT scan	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.	one day