This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients requiring transpedicular screw fixation. The study, conducted in two different hospital centers, involves patients with vertebral fractures, spinal stenosis, kyphosis, and other related conditions. The primary objective is to determine screw accuracy by assessing the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement. Trained radiologists will evaluate the screw invasion into the pedicle. The study is scheduled to span 12 months and each intervention includes a 1-month follow-up. Throughout this time frame, patients will undergo regular assessments, and outcomes will be closely monitored.
Multicenter non-comparative clinical trial. This interventional study aims to assess the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients requiring transpedicular screw fixation.The primary focus is on overcoming the limitations of traditional minimally invasive surgeries and enhancing the accuracy of pedicle screw placement, especially within the complex pedicle region adjacent to the spinal canal. The study design is a prospective interventional trial conducted in two hospital centers in Spain, with two principal investigators leading the investigation. Patients requiring transpedicular screw fixation will be recruited. The robotic assistant will be employed to facilitate transpedicular screw fixation. The system aims to improve accuracy and safety in screw placement, in comparison with conventional techniques used. Patients will include individuals with spinal fractures, spinal stenosis, kyphosis, and other conditions requiring transpedicular screw fixation. Two principal investigators in Spain will lead the recruitment process. The study aims to answer several key questions: * Determine Screw Accuracy: Assess the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement. * Evaluate Planning vs. Final Screw Placement: Determine the accuracy of screw placement by comparing planned positions with the actual final positions. * System Performance: Assess the overall performance of the robotic system during the surgical procedure. * Reoperation and Postoperative Time: Determine the need for reoperation and evaluate postoperative recovery time. * Adverse Events: Detect and document any adverse events occurring during the surgical process. Trained radiologists will play a crucial role in evaluating the accuracy of screw placement, focusing on the degree of invasion into the pedicle using the Gertzbein-Robbins scale. The study is set to span a duration of 12 months,during which patients will undergo regular assessments, and outcomes will be closely monitored. The inclusion of the electromechanical tracking system in the robotic assistant adds a technological dimension to the investigation, contributing to advancements in the field of minimally invasive spinal surgeries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
13
Surgical technique which joins two or more vetebrae with screws and rods to prevent any relative movement between them. It is a major surgery that usually lasts several hours and in which the patient is subjected to general anesthesia. The screws to be placed go through a narrow area of the vertebra known as the pedicle. Each patient will undergo a singular intervention.
Cyber Surgery
Donostia / San Sebastian, Gipuzkoa, Spain
Grade of screw invasion into the pedicle based on Gertzbein-Robbins scale (A-E grade)
Grade A: Screw position within the pedicle. Grade B: Cortical breakage ≤2mm. Grade C: Cortical breakage ≤4mm. Grade D: Cortical breakage ≤6mm. Grade E: Cortical breakage \>6mm.
Time frame: 1 month follow-up
Patient characteristics - Demographic dates - Sex (Male/Female)
Time frame: 3 months
Patient characteristics - Demographic dates - Age (years)
Time frame: 3 months
Patient characteristics - Demographic dates - Weight (kg)
Time frame: 3 months
Patient characteristics - Demographic dates - Height (cm)
Time frame: 3 months
Patient characteristics - BMI
W \[kg\]/H \[m2\]
Time frame: 3 months
Patient characteristics - Spinal Region (Thoracic/Lumbar/Sacral)
Time frame: 3 months
Patient characteristics - Vertebrae for study (T1...T12/L1...L5/S1-S2)
Time frame: 3 months
Patient characteristics - Comobidities
Charlson Index (1-6 pts)
Time frame: 3 months
Patient characteristics - Number of screws to be placed
Time frame: 3 months
Implant characteristics - Planned vertebrae
Time frame: 3 months
Implant characteristics - Laterality (L/R)
Time frame: 3 months
Implant characteristics - Screw orientation in sagittal plane (Cranial/Caudal/Neutral)
Time frame: 3 months
Implant characteristics - Screw orientation in axial plane (Medial/Lateral/Neutral)
Time frame: 3 months
Implant characteristics - Screw dimensions - Screw diameter (mm)
Time frame: 3 months
Implant characteristics - Screw dimensions - Screw length (mm)
Time frame: 3 months
Clinical Intervention - Surgical technique (open/MIS)
Time frame: 3 months
Clinical Intervention - ASA Anaesthesia (I-IV)
Time frame: 3 months
Clinical Intervention - Radiation emission - Time (sec.)
Time frame: 3 months
Clinical Intervention - Radiation emission - Dosage (mGy)
Time frame: 3 months
Clinical Intervention - Blood loss - Intraoperatice blood loss (ml)
Time frame: 3 months
Clinical Intervention - Blood loss - Number of gauzes used
Time frame: 3 months
Clinical Intervention - Blood loss - Postoperative drainage (ml)
Time frame: 3 months
Clinical Intervention - Blood loss - Duration of surgery - Total (min.)
Time frame: 3 months
Clinical Intervention - Blood loss - Duration of surgery per stages - Power on and disposition (min.)
Time frame: 3 months
Clinical Intervention - Blood loss - Duration of surgery per stages - Planification (min.)
Time frame: 3 months
Clinical Intervention - Blood loss - Duration of surgery per stages - Image registration (min.)
Time frame: 3 months
Clinical Intervention - Blood loss - Duration of surgery per stages - Positioning (min.)
Time frame: 3 months
Clinical Intervention - Blood loss - Duration of surgery per stages - Surgery (min.)
Time frame: 3 months
Clinical Intervention - Blood loss - Duration of surgery per stages - Removal and power off (min.)
Time frame: 3 months
Clinical Intervention - Blood loss - Postoperative stay (days)
Time frame: 1 month follow-up
System performance - Number of image registration
Time frame: 1 month follow-up
System performance - Number of screws not inserted using the robotic assistant
Time frame: 1 month follow-up
System performance - Number of colisioned screws
Time frame: 1 month follow-up
System performance - Number of not reachable screws
Time frame: 1 month follow-up
System performance - Fiducial Registration Error, FRE (mm)
Time frame: 3 months
System performance - Screw position deviation - Spatial deviation in XY plane (mm)
Time frame: 1 month follow-up
System performance - Screw position deviation - Spatial deviation in XZ plane (mm)
Time frame: 1 month follow-up
System performance - Screw position deviation - Spatial deviation in YZ plane (mm)
Time frame: 1 month follow-up
System performance - Screw position deviation - Angular deviation in XY plane (deg.)
Time frame: 1 month follow-up
System performance - Screw position deviation - Angular deviation in XZ plane (deg.)
Time frame: 1 month follow-up
System performance - Screw position deviation - Angular deviation in YZ plane (deg.)
Time frame: 1 month follow-up
Adverse Events, AE
Time frame: 1 month follow-up
Severe Adverse Events, SAE
Time frame: 1 month follow-up
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