Safety Trial of Patient Specific Guides for Lumbar Fusion

Lawson Health Research Institute

Status: Unknown

Conditions: Orthopedic Disorder of Spine

Treatments: Procedure: Patient Specific Guide; Procedure: Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04751981

10079 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Patient Specific Guide

Experimental group

Description:

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

Treatment:

Procedure: Patient Specific Guide

Navigation

Other group

Description:

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

Treatment:

Procedure: Navigation