Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care

NCT06554093 | Not Yet Recruiting

• 2 other identifiers: CL0003341268
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

fusion; screw positioning; screw insertion

Outcome Measures

Primary Outcomes (1)

• Accuracy of the screw implantation by Gertzbein-Robbins scale

  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 Outcomes (2)

• Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.

  24 hours after surgery

• Evaluate time-per-screw for the experimental device arm (PKS) arm.

  Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)

Study Arms (2)

Medical Device- PathKeeper System (PKS)

EXPERIMENTAL

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

2D Fluoroscopy

ACTIVE COMPARATOR

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

Interventions

Medical Device - PKS DEVICE

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.

Also known as: Device- Fluoroscopy

2D Fluoroscopy; Medical Device- PathKeeper System (PKS)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Deep Health Ltd.: lead

Study Sites (1)

Leeds Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Scoliosis; Fractures, Spontaneous

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: • 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. 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. • 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.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: August 14, 2024
• Study Start: October 30, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)