Orthopedic Disorder of Spine
Conditions
Keywords
Patient Specific Guides, Lumbar Fusion, Spine
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.
Interventions
PROCEDUREPatient Specific Guide
For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
PROCEDURENavigation
Conventional navigation will be used to place pedicle screws.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screw trajectory deviation | Day 1 | Measured as the angle in degrees deviated from the planned trajectory |
| Screw start point deviation | Day 1 | Measured as distance in millimeters from the planed start point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pedicle Breach | Day 1 | Number, location and severity of any pedicle breaches |
| Adverse Event Rate & Serious Adverse Events | Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks | Measured intra-operatively and post-operatively |
| Guide Reliability | Day 1 | 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. |
Outcome results
None listed