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

Deep Health

Status: Not yet enrolling

Conditions: Scoliosis Kyphosis; Scoliosis Thoracic Region; Scoliosis; Adolescence; Scoliosis; Scoliosis Lumbar Region; Pathologic Fracture

Treatments: Device: Medical Device - PKS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06554093

341268 (Other Identifier)

CL0003

Details and patient eligibility

About

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

Full 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

Enrollment: 32 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Medical Device- PathKeeper System (PKS)

Experimental group

Description:

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.

Treatment:

Device: Medical Device - PKS

2D Fluoroscopy

Active Comparator group

Description:

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

Treatment:

Device: Medical Device - PKS