Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eCential Robotics solution.
- Who it may be relevant to
- Registry conditions: Pedicle Screw Accuracy, Robot, Navigation, Spine. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery at Amiens Picardie University Hospital
Overview
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
- Procedure eCential 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 patien
Primary outcome measures
- Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale [Time frame: 12 months]
Secondary outcome measures (10)
- Per-operative Blood loss (ml) [Time frame: day 0]
- Per-operative Operative time (min) [Time frame: day 0]
- Per-operative X-ray exposure dose (mGy.cm2) [Time frame: day 0]
- Per-operative Hardware or software malfunction [Time frame: day 0]
- Per-operative Intraoperative complication [Time frame: day 0]
- Per-operative Complication [Time frame: day 0]
- Immediate post-operative Discharge time (days) [Time frame: up to 12 months]
- Immediate post-operative Length of hospital stay (days) [Time frame: up to 12 months]
- Immediate post-operative Adverse events [Time frame: up to 12 months]
- 9-month follow-up Adverse events [Time frame: at 9 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT07421752 · PI2024_843_0119