Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery (Robotec Amiens)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis; Spine; Navigation; Pedicle Screw Accuracy; Robot
• Intervention / Treatment: Procedure: eCential Robotics solution

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François DEROUSSEN, MD; Phone Number: 33+322087576; Email: deroussen.francois@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens
    • Contact: Francois Deroussen, MD; Phone Number: (33)322087576; Email: deroussen.francois@chu-amiens.fr
    • Sub-Investigator: Richard Gouron, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Per-operative Hardware or software malfunction (Yes/No)	day 0
Per-operative Intraoperative complication		day 0
Per-operative Complication	Per-operative Complication (adverse events table)	day 0
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	Immediate post-operative Adverse events (table)	up to 12 months
9-month follow-up Adverse events	9-month follow-up Adverse events (table)	at 9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: scoliosis; spine; robot; navigation; Pedicle screw accuracy
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: PI2024_843_0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No