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Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
Sponsor: Deep Health Ltd.
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
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
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-10-30
Completion Date
2025-10-30
Last Updated
2025-02-05
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Leeds Hospital
Leeds, West Yorkshire, United Kingdom