Actively Recruiting
Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery at Amiens Picardie University Hospital
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-02-19
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of the eCential Robotics surgical robot to improve the precision and safety of spinal surgery, especially for placing pedicle screws. This prospective study aims to confirm the safety, performance, and clinical benefits of this robotic system, which allows advanced preoperative planning using three-dimensional imaging to better understand each patient's anatomy. The research supports the CE marking process for this innovative technology. The study evaluates the eCential Robotics solution, a unified platform combining 2D/3D imaging, navigation, and robotics. The procedure involves patient reference setup on spinal processes, low-dose 2D and 3D imaging with a motorized X-ray C-arm, intraoperative implant planning, navigation using pre-calibrated instruments, and collaborative robot-surgeon handling to align pedicle aiming instruments. Real-time 3D visualization guides the procedure, and 3D imaging is used to verify screw placement. Participants will undergo spinal surgery using the robotic system and will be monitored for pedicle screw accuracy using the Gertzbein-Robbins Scale over 12 months. Additional outcomes include blood loss, operative time, X-ray exposure, hardware or software malfunctions, complications during and after surgery, discharge time, hospital stay length, and adverse events up to 12 months post-operation. The study begins with surgery and continues with follow-up assessments to evaluate safety and effectiveness over time.
CONDITIONS
Brief Title
Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 5 years or older
- Patients treated at CHU Amiens Picardie for spinal surgery requiring pedicle screw implantation
- Signed informed consent from the patient or legal representative and the child
- Membership of a social security scheme
- Negative pregnancy test for adolescent females of childbearing age
You will not qualify if you...
- Patients managed by a practitioner without experience using the eCential Robotics robot
- Patients requiring spinal surgery without pedicle screw implantation
- Patients already suffering from deterministic radiation effects
- Pregnant, parturient, or breastfeeding women
- Patients under guardianship, curatorship, safeguard of justice, or deprived under public law
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0 to hospital discharge
Participants undergo spinal surgery using the eCential Robotics robot for pedicle screw implantation, followed by immediate post-operative monitoring.
1 surgical visit and hospital stay
Duration - Up to 12 months
Participants are followed up to monitor adverse events, complications, and hardware accuracy for up to 12 months after surgery.
Visits at hospital discharge and follow-ups up to 12 months, including a 9-month visit
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80054
Actively Recruiting
Research Team
F
François DEROUSSEN, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
0
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