Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery with Traditional Care (PKSforPSP)

February 3, 2025 updated by: Deep Health Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Leeds Hospital
        • Contact:
        • Contact:
          • Almas Khan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women
  • 16 and above years old
  • Patients who are about to undergo open, instrumented spinal surgery
  • Signed informed consent form

Exclusion Criteria:

  • Men and women
  • 16 and above years old
  • Patients who are about to undergo open, instrumented spinal surgery
  • Signed informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical Device- PathKeeper System (PKS)

One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.

Intervention: Medical Device - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.
Device: Medical Device - PKS
The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.
Other Names:
  • Device- Fluoroscopy
Active Comparator: 2D Fluoroscopy
Control arm: Standard of care - 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
Device: Medical Device - PKS
The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.
Other Names:
  • Device- Fluoroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the screw implantation by Gertzbein-Robbins scale
Time Frame: Post-operative CT scan to be performed before hospital discharge and evaluation can be done right after or at the end of the of the data collection
Mean and STD of Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan
Post-operative CT scan to be performed before hospital discharge and evaluation can be done right after or at the end of the of the data collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.
Time Frame: 24 hours after surgery
Mean and STD Values in milli-gray (mGy) and seconds collected from the c-Arm
24 hours after surgery
Evaluate time-per-screw for the experimental device arm (PKS) arm.
Time Frame: Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)
Operative time per screw
Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deep Health Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2025

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0003
  • 341268 (Other Identifier: IRAS(Integrated research application system))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To be done

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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