Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-06 @ 1:16 PM
Study NCT ID:
NCT06554093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
Sponsor:
Deep Health Ltd.
Organization:
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:
False
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 question\[s\]it 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:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 341268 | OTHER | IRAS(Integrated research application system) | View |