NCT07421752

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Nov 2025Nov 2028

Study Start

First participant enrolled

November 21, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

February 19, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

February 10, 2026

Last Update Submit

February 17, 2026

Conditions

Pedicle Screw AccuracyRobotNavigationSpineScoliosis

Keywords

Pedicle screw accuracyrobotnavigationspinescoliosis

Outcome Measures

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.

    12 months

Secondary Outcomes (10)

  • 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 Intraoperative complication

    day 0

  • +5 more secondary outcomes

Interventions

eCential Robotics solutionPROCEDURE

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

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

François DEROUSSEN, MD

CONTACT

33+322087576deroussen.francois@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 19, 2026

Study Start

November 21, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

February 19, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)