Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
Spinal surgery has evolved considerably over the years, and the introduction of advanced technologies has played a crucial role in improving clinical outcomes. The use of surgical robots, such as the eCential Robotic system, has emerged as an innovative solution for optimizing the precision and safety of procedures, particularly the placement of pedicle screws in the spine.
The eCential Robotics surgical robot offers several advantages for the placement of pedicle screws in the spine. Various studies have demonstrated a significant improvement in screw accuracy and stability, reducing revision surgery rates with surgical robots. The system enables advanced preoperative planning based on three-dimensional imaging, improving understanding of the patient's specific anatomy. This study will also provide a clinical basis for the CE marking process.
The objective of this prospective study is to collect data confirming safety, performance and clinical benefits of the eCential Robotics robot when used during spine and pelvic surgeries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
eCential Robotics solution
Procedure/SurgeryThe robotic aid is adaptable to all cannulated pedicle screw implantations in spine surgery. The eCential Robotics solution consists of a unified platform combining 2D/3D imaging, navigation and robotics. The procedure consists of : * Setting up the patient reference on the patient's spinal processes * 2D then 3D imaging (low-dose technology, using a 5-axis motorized X-ray C-arm to optimize trajectory and increase reconstruction volume) * Intraoperative planning of implants based on the patient's image in the operating position * Navigation: automatic matching of patient and 3D imagery with factory pre-calibrated single-use instruments. Real-time visualization of the trajectory in the 3D image. * Robotic surgery: collaborative robot-surgeon handling. Automatic alignment of pedicle aiming instruments with workflow control from the sterile zone. * 3D imaging to control screw positioning
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale. perfect intra-pedicular localization without any cortical breach (Grade A) * \< 2 mm pedicle breach (Grade B) * \< 4 mm pedicle breach (Grade C) * \< 6 mm pedicle breach (Grade D) * ≥ 6 mm pedicle breach (Grade E) Screws graded A and B are clinically acceptable, screws graded C, D, E have a significant deviation from the intended trajectory.
Time frame
12 monthsSecondary outcomes
1
Per-operative Blood loss (ml)
Time frame
day 02
Per-operative Operative time (min)
Time frame
day 03
Per-operative X-ray exposure dose (mGy.cm2)
Time frame
day 04
Per-operative Hardware or software malfunction
Per-operative Hardware or software malfunction (Yes/No)
Time frame
day 0Sponsors and contacts
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Source ClinicalTrials.gov