Safety Trial of Patient Specific Guides for Lumbar Fusion

NCT04751981 | Unknown

• 1 other identifier: 10079
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Patient Specific Guides; Lumbar Fusion; Spine

Outcome Measures

Primary Outcomes (2)

• Screw trajectory deviation

  Measured as the angle in degrees deviated from the planned trajectory

  Day 1

• Screw start point deviation

  Measured as distance in millimeters from the planed start point.

  Day 1

Secondary Outcomes (3)

• Pedicle Breach

  Day 1

• Adverse Event Rate & Serious Adverse Events

  Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks

• Guide Reliability

  Day 1

Study Arms (2)

Patient Specific Guide

EXPERIMENTAL

Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides.

Procedure: Patient Specific Guide

Navigation

OTHER

Patients randomized into this group will have pedicle screws placed with conventional navigation.

Procedure: Navigation

Interventions

Patient Specific Guide PROCEDURE

For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.

Patient Specific Guide

Navigation PROCEDURE

Conventional navigation will be used to place pedicle screws.

Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or over
• Indication for lumbar spine surgery requiring pedicle screw instrumentation through a posterior approach with fusion.
• Recently has or requires a CT-scan of the spine
• No previous spine surgery on the level being used for patient specific guides
• Sufficient understanding of the English language or interpretation assistance available.

You may not qualify if:

• History of alcohol or drug abuse
• History of psychiatric disorders
• Previous spine surgery adjacent or at the level of the surgery
• Unable to read or comprehend the consent form/letter of information

Sponsors & Collaborators

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

Study Design

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

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 12, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 12, 2021

Record last verified: 2021-01