Safety Trial of Patient Specific Guides for Lumbar Fusion

Orthopedic Disorder of Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04751981
• Other study ID #: 10079
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: February 2023

Study information

• Verified date: January 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder of Spine
• Spinal Diseases

Intervention

Procedure:
• Patient Specific Guide
For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
• Navigation
Conventional navigation will be used to place pedicle screws.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screw trajectory deviation	Measured as the angle in degrees deviated from the planned trajectory	Day 1
Primary	Screw start point deviation	Measured as distance in millimeters from the planed start point.	Day 1
Secondary	Pedicle Breach	Number, location and severity of any pedicle breaches	Day 1
Secondary	Adverse Event Rate & Serious Adverse Events	Measured intra-operatively and post-operatively	Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks
Secondary	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