Spine surgery showdown: robot vs. Surgeon's hand
NCT ID NCT05553028
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares robot-assisted spine surgery to the traditional method in 300 adults needing spinal fusion. The goal is to see if the robot helps place screws more accurately, reduces complications, and improves patient outcomes. Participants are randomly assigned to either robot-assisted or conventional surgery, and results are evaluated by independent radiologists.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- robot-assisted surgery (Mazor X Stealth)
- What this could lead to
- If successful, this could show that robot-assisted spine surgery is safer and more precise than traditional methods, potentially reducing complications and improving recovery.
- What could go wrong
- This is a single-center study with 300 participants, so results may not apply to all hospitals or patients. The robot may not improve outcomes enough to justify its cost.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2022
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Clinique Saint Martin
Pessac, 33600, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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