Navigation, Pedicle Screw Accuracy, Robot, Scoliosis, Spine
Conditions
Keywords
Pedicle screw accuracy, robot, navigation, spine, scoliosis
Brief summary
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.
Interventions
PROCEDUREeCential Robotics solution
The 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
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-operative Blood loss (ml) | day 0 | — |
| Per-operative Operative time (min) | day 0 | — |
| Per-operative X-ray exposure dose (mGy.cm2) | day 0 | — |
| Per-operative Hardware or software malfunction | day 0 | Per-operative Hardware or software malfunction (Yes/No) |
| Per-operative Intraoperative complication | day 0 | — |
| Per-operative Complication | day 0 | Per-operative Complication (adverse events table) |
| Immediate post-operative Discharge time (days) | up to 12 months | — |
| Immediate post-operative Length of hospital stay (days) | up to 12 months | — |
| Immediate post-operative Adverse events | up to 12 months | Immediate post-operative Adverse events (table) |
| 9-month follow-up Adverse events | at 9 months | 9-month follow-up Adverse events (table) |
Countries
France
Contacts
CONTACTFrançois DEROUSSEN, MD
Outcome results
None listed