eCential Robotics robot for more accurate pedicle screw placement in spine surgery
Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery at Amiens Picardie University Hospital
NA · Centre Hospitalier Universitaire, Amiens · NCT07421752
This will test whether using the eCential Robotics robot improves the accuracy and safety of pedicle screw placement in patients aged 5 and older undergoing spine surgery, including for scoliosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Amiens) |
| Trial ID | NCT07421752 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center study at CHU Amiens collecting clinical and imaging data on patients who undergo robot-assisted pedicle screw implantation using the eCential Robotics solution. Surgeons will use three-dimensional preoperative imaging and the robotic navigation system to plan and execute screw placement, and outcomes such as screw position accuracy, safety events, and need for revision will be recorded. Eligible patients are aged 5 years or older and require pedicle screws as part of their spinal procedure; key exclusions include pregnancy, prior deterministic radiation effects, treatment by surgeons without robot experience, and conservatorship status. Collected data will be used to confirm device performance and safety and to support the CE marking process.
Who should consider this trial
Good fit: Ideal candidates are patients aged 5 or older treated at CHU Amiens who need pedicle screw implantation for spine conditions such as scoliosis and can give informed consent.
Not a fit: Patients who do not require pedicle screws, are pregnant or breastfeeding, have prior deterministic radiation injury, are under legal guardianship, or would be treated by clinicians without robot experience are unlikely to benefit.
Why it matters
Potential benefit: If successful, the robot could increase pedicle screw placement accuracy, lower revision rates, and improve overall surgical safety.
How similar studies have performed: Previous studies of robotic-assisted pedicle screw placement have generally reported improved accuracy and reduced revision rates, although methods and devices differ and high-quality comparative evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 5 years or older. * Treated at CHU Amiens Picardie for spinal surgery requiring implantation of pedicle screws. * Informed consent signed by patient or legal representative and child. * Membership of a social security scheme. * Negative pregnancy test for adolescent women of childbearing age Exclusion Criteria: * Patient managed by a practitioner with no experience of the eCential Robotics robot. * Patient requiring a technique without implantation of pedicle screws. * Patients already suffering from deterministic radiation effects * Pregnant, parturient or breast-feeding women. * Patients under guardianship or curators, under safeguard of justice or deprived under public law.
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (RECRUITING)
Study contacts
- Study coordinator: François DEROUSSEN, MD
- Email: deroussen.francois@chu-amiens.fr
- Phone: 33+322087576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pedicle Screw Accuracy, Robot, Navigation, Spine, Scoliosis, Pedicle screw accuracy, robot, navigation