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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 :
|
| 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)
| 12 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François DEROUSSEN, MD | Contact | 33+322087576 | deroussen.francois@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Recruiting | Amiens | 80054 | France |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |