The PathKeeper System for Pedicle Screw Positioning in Spine Surgery
Research type
Research Study
Full title
A prospective, dual center, double armed, open label, clinical Study to Evaluate the Performance of the PathKeeper System for Pedicle Screw Positioning in spine surgery.
IRAS ID
341268
Contact name
Almas Khan
Contact email
Sponsor organisation
PathKeeper Surgical Ltd.
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The PathKeeper System is a stereotaxic image guidance system. It is intended to be used to correctly position and orient the instruments used during surgical procedures performed by neurosurgeons and orthopaedic surgeons. The System uses PathKeeper spine surgery planning software, spine surgery navigation software, and a 3D optical camera to accurately locate anatomical structures encountered during the surgical procedure.
The system uses preoperative computed tomography (CT) data along with intraoperative Optical Topographic Image (OTI) data which is captured using a OTI 3D camera. The system provides surgical guidance data by displaying the location of optically tracked surgical accessories (such as pedicle screws) relative to the patient's anatomy in the area where the surgery is being performed, position and orientation data of PathKeeper’s Surgical Accessories are linked to the pre-operative scan data using a workstation.
The PathKeeper System is designed for use in open spine surgery where reference to a rigid structure (the spinal column) can be identified relative to the pre-operative image data of the patient's anatomy. In open spine surgery the posterior (rear facing) elements of the vertebrae to be operated on are exposed, either on one (unilaterally) or both (bilaterally) sides of the column. PathKeeper System’s 3D image-processing capabilities match the topography of exposed bone structures (obtained by the OTI 3D camera), to the CT scans of the patient taken prior to surgery.
The overall objective of the study is to compare the performance of the PathKeeper System versus the current standard "freehand" method that is used in the UK which uses 2D Fluoroscopy to help direct implantation of pedicle screws.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0200
Date of REC Opinion
29 Oct 2024
REC opinion
Further Information Favourable Opinion