Back to resultsSafety Trial of Patient Specific Guides for Lumbar Fusion
Primary Purpose
Orthopedic Disorder of Spine
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient Specific Guide
Navigation
Sponsored by
About this trial
This is an interventional basic science trial for Orthopedic Disorder of Spine focused on measuring Patient Specific Guides, Lumbar Fusion, Spine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Patient Specific Guide
Navigation
Arm Description
Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides.
Patients randomized into this group will have pedicle screws placed with conventional navigation.
Outcomes
Primary Outcome Measures
Screw trajectory deviation
Measured as the angle in degrees deviated from the planned trajectory
Screw start point deviation
Measured as distance in millimeters from the planed start point.
Secondary Outcome Measures
Pedicle Breach
Number, location and severity of any pedicle breaches
Adverse Event Rate & Serious Adverse Events
Measured intra-operatively and post-operatively
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.
Full Information
NCT ID
NCT04751981
First Posted
January 27, 2021
Last Updated
February 8, 2021
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04751981
Brief Title
Safety Trial of Patient Specific Guides for Lumbar Fusion
Official Title
A Safety Trial for Evaluating Patient Specific Guides Accuracy for Pedicle Screw Insertion in Lumbar Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder of Spine
Keywords
Patient Specific Guides, Lumbar Fusion, Spine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient Specific Guide
Arm Type
Experimental
Arm Description
Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides.
Arm Title
Navigation
Arm Type
Other
Arm Description
Patients randomized into this group will have pedicle screws placed with conventional navigation.
Intervention Type
Procedure
Intervention Name(s)
Patient Specific Guide
Intervention Description
For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
Intervention Type
Procedure
Intervention Name(s)
Navigation
Intervention Description
Conventional navigation will be used to place pedicle screws.
Primary Outcome Measure Information:
Title
Screw trajectory deviation
Description
Measured as the angle in degrees deviated from the planned trajectory
Time Frame
Day 1
Title
Screw start point deviation
Description
Measured as distance in millimeters from the planed start point.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Pedicle Breach
Description
Number, location and severity of any pedicle breaches
Time Frame
Day 1
Title
Adverse Event Rate & Serious Adverse Events
Description
Measured intra-operatively and post-operatively
Time Frame
Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks
Title
Guide Reliability
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Safety Trial of Patient Specific Guides for Lumbar Fusion
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