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Safety Trial of Patient Specific Guides for Lumbar Fusion

NCT04751981 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-02-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2023-02-28
Completion
2023-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751981 on ClinicalTrials.gov