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NCT Number: NCT07421752

Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery

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.

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Key information

Conditions

Pedicle Screw Accuracy Bone Diseases Musculoskeletal Diseases Navigation Robot Scoliosis Spinal Curvatures Spinal Diseases Spine

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

Location status: Recruiting

Location contact

Francois Deroussen, MD

CONTACT

[email protected]

(33)322087576

Richard Gouron, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eCential Robotics solution

Procedure

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

Primary outcomes

  1. Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale

    Time frame: 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 outcomes

  1. Per-operative Blood loss (ml)

    Time frame: day 0

  2. Per-operative Operative time (min)

    Time frame: day 0

  3. Per-operative X-ray exposure dose (mGy.cm2)

    Time frame: day 0

  4. Per-operative Hardware or software malfunction

    Time frame: day 0

    Per-operative Hardware or software malfunction (Yes/No)

  5. Per-operative Intraoperative complication

    Time frame: day 0

  6. Per-operative Complication

    Time frame: day 0

    Per-operative Complication (adverse events table)

  7. Immediate post-operative Discharge time (days)

    Time frame: up to 12 months

  8. Immediate post-operative Length of hospital stay (days)

    Time frame: up to 12 months

  9. Immediate post-operative Adverse events

    Time frame: up to 12 months

    Immediate post-operative Adverse events (table)

  10. 9-month follow-up Adverse events

    Time frame: at 9 months

    9-month follow-up Adverse events (table)

Study contacts

Contact information is provided by the study sponsor or research team.

François DEROUSSEN, MD

CONTACT

[email protected]

33+322087576

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery at Amiens Picardie University Hospital

Acronym: Robotec Amiens

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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