NCT04751981

Safety Trial of Patient Specific Guides for Lumbar Fusion

A Safety Trial for Evaluating Patient Specific Guides Accuracy for Pedicle Screw Insertion in Lumbar Fusion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre, non-blinded safety trial. Patients undergoing lumbar fusion will be treated using patient specific guides (PSG) or navigation. Patients requiring lumbar fusion will be treated using conventional surgical methods except when inserting pedicle screws, where half of the patients will be having screws inserted using PSGs. The conventional method of navigation and intraoperative imaging will be used in conjunction with PSGs, to confirm the safety of the guide trajectory. The primary outcome will be screw accuracy measured in degrees from planned trajectory and mm from the planned entry point.

Conditions

• Orthopedic Disorder of Spine

Interventions

Type	Name	Description
PROCEDURE	Patient Specific Guide	For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
PROCEDURE	Navigation	Conventional navigation will be used to place pedicle screws.

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-02-12
• Last updated: 2021-02-12