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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Specific Guide | Experimental | Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides. |
|
| Navigation | Other | Patients randomized into this group will have pedicle screws placed with conventional navigation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Specific Guide | Procedure | For lumbar fusion pedicle screws will be placed with the aid of patient specific guides. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pedicle Breach | Number, location and severity of any pedicle breaches | Day 1 |
| Adverse Event Rate & Serious Adverse Events | Measured intra-operatively and post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Navigation | Procedure | Conventional navigation will be used to place pedicle screws. |
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| 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. | Day 1 |