Back to resultsStudy 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)
Primary Purpose
Osteosynthesis, Mazor Robot, Spinal Surgery
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computerised tomography
Sponsored by
About this trial
This is an interventional treatment trial for Osteosynthesis
Eligibility Criteria
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.
Sites / Locations
- Clinique Saint MartinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot assisted surgery
Conventional surgery
Arm Description
Patient operated for thoracic and/or lumbar spine arthrodesis with robot assistance Mazor
Patient operated for thoracic and/or lumbar spine arthrodesis with conventional surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05553028
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosynthesis, Mazor Robot, Spinal Surgery, Arthrosis; Spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot assisted surgery
Arm Type
Experimental
Arm Description
Patient operated for thoracic and/or lumbar spine arthrodesis with robot assistance Mazor
Arm Title
Conventional surgery
Arm Type
Active Comparator
Arm Description
Patient operated for thoracic and/or lumbar spine arthrodesis with conventional surgery
Intervention Type
Procedure
Intervention Name(s)
Computerised tomography
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of screw placement by a CT scan
Description
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.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas AUROUER, Dr
Phone
06 21 98 82 44
Email
nicolas.aurouer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jeanfrancois.oudet@free.fr
Facility Information:
Facility Name
Clinique Saint Martin
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AUROUER, MD
Email
recherche.na@elsan.care
12. IPD Sharing Statement
Learn more about this 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
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