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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale [Срок оценки: 12 months]

Вторичные конечные точки (10)

• Per-operative Blood loss (ml) [Срок оценки: day 0]
• Per-operative Operative time (min) [Срок оценки: day 0]
• Per-operative X-ray exposure dose (mGy.cm2) [Срок оценки: day 0]
• Per-operative Hardware or software malfunction [Срок оценки: day 0]
• Per-operative Intraoperative complication [Срок оценки: day 0]
• Per-operative Complication [Срок оценки: day 0]
• Immediate post-operative Discharge time (days) [Срок оценки: up to 12 months]
• Immediate post-operative Length of hospital stay (days) [Срок оценки: up to 12 months]
• Immediate post-operative Adverse events [Срок оценки: up to 12 months]
• 9-month follow-up Adverse events [Срок оценки: at 9 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU Amiens — Amiens

Идентификаторы

NCT: NCT07421752 · PI2024_843_0119

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗