Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554093
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-12
Brief Title:
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Dual Canter Double Armed Open Label Clinical Study to Evaluate the Performance of the PathKeeper System for Pedicle Screw Positioning in Spine Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PKSforPSP
Brief Summary:
The goal of this is to evaluate performance of the Pathkeeper Surgical System The main questionsit aims to answer are 1 evaluate pedicle screw position Participants will in compare Experimental arm PathKeeper System PKS with control arm
Detailed Description:
Trial design
Allocation Randomized
Interventional Model Parallel Assignment double armed
Interventional Model Description Dual center prospective randomized cohort study
Masking None Open Label
Primary Purpose Treatment
Enrolment 32 thirty-two patients - 16 sixteen patients experimental and 16 control arms 100 screws each arm estimated 20 of patients drop out
Study arms
1 Experimental arm PathKeeper System PKS One to ten-level posterior open instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance
Interventions Medical Devise - PKS The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels
2 Control arm free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior open instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy
Interventions Pedicle screws will be placed using the free-hand technique with 2D fluoroscopy as the intraoperative imaging modality
Primary endpoints
Evaluate and classify the pedicle screw positions as per the Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan in each study arm and comparatively
Number of misaligned screws as per the Gertzbein-Robbins classification scale Gertzbein and Robbins 1990 class E screws class D screws class C screws class B screws class A screws
Secondary endpoints
1 Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively
2 Evaluate time-per-screw for the experimental device arm PKS arm
3 Length of stay - non-critical
4 Estimated blood loss EBL - non-critical
5 Number of reported complications neurological deficits dural tears deep wound infections etc while hospitalized
Allocation Randomized
Interventional Model Parallel Assignment double armed
Interventional Model Description Dual center prospective randomized cohort study
Masking None Open Label
Primary Purpose Treatment
Enrolment 32 thirty-two patients - 16 sixteen patients experimental and 16 control arms 100 screws each arm estimated 20 of patients drop out
Study arms
1 Experimental arm PathKeeper System PKS One to ten-level posterior open instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance
Interventions Medical Devise - PKS The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels
2 Control arm free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior open instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy
Interventions Pedicle screws will be placed using the free-hand technique with 2D fluoroscopy as the intraoperative imaging modality
Primary endpoints
Evaluate and classify the pedicle screw positions as per the Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan in each study arm and comparatively
Number of misaligned screws as per the Gertzbein-Robbins classification scale Gertzbein and Robbins 1990 class E screws class D screws class C screws class B screws class A screws
Secondary endpoints
1 Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively
2 Evaluate time-per-screw for the experimental device arm PKS arm
3 Length of stay - non-critical
4 Estimated blood loss EBL - non-critical
5 Number of reported complications neurological deficits dural tears deep wound infections etc while hospitalized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None