UnknownNot Applicable

Safety Trial of Patient Specific Guides for Lumbar Fusion

80 participantsStarted 2021-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Screw trajectory deviation

Timeframe: Day 1

Screw start point deviation

Timeframe: Day 1

Trial details

NCT IDNCT04751981

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02

View on ClinicalTrials.gov More Orthopedic Disorder of Spine trials