Safety Trial of Patient Specific Guides for Lumbar Fusion

Study Overview
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Brief Summary
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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.

Official Title
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A Safety Trial for Evaluating Patient Specific Guides Accuracy for Pedicle Screw Insertion in Lumbar Fusion

Conditions
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Orthopedic Disorder of Spine

Intervention / Treatment
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* Procedure: Patient Specific Guide
* Procedure: Navigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Specific Guide<br>Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides. | Procedure: Patient Specific Guide<br>* For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.<br>|
| Other: Navigation<br>Patients randomized into this group will have pedicle screws placed with conventional navigation. | Procedure: Navigation<br>* Conventional navigation will be used to place pedicle screws.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Specific Guides, Lumbar Fusion, Spine