Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153511
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2023-11-16
Brief Title:
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
Sponsor:
Cyber Surgery SL
Organization:
Cyber Surgery SL
Study Overview
Official Title:
Clinical Investigation With a Robotic Assistant for Spinal Surgery in Patients Requiring a Transpedicular Fixation
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 fixationThe 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 monthsduring 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
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 fixationThe 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 monthsduring 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None