Safety Trial of Patient Specific Guides for Lumbar Fusion

N/AUnknownNCT04751981

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Orthopedic Disorder of Spine

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Screw trajectory deviation

Measured as the angle in degrees deviated from the planned trajectory

Time frame: Day 1

Screw start point deviation

Measured as distance in millimeters from the planed start point.

Time frame: Day 1

Secondary Outcomes

Pedicle Breach

Number, location and severity of any pedicle breaches

Time frame: Day 1

Adverse Event Rate & Serious Adverse Events

Measured intra-operatively and post-operatively

Time frame: Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks

Guide Reliability

The reliability of patient specific guides will be measured as the number of cases that used the guides divided by the total number of cases in which guides were planned to be used.

Time frame: Day 1