Safety Trial of Patient Specific Guides for Lumbar Fusion

February 8, 2021 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screw trajectory deviation
Time Frame: Day 1
Measured as the angle in degrees deviated from the planned trajectory
Day 1
Screw start point deviation
Time Frame: Day 1
Measured as distance in millimeters from the planed start point.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pedicle Breach
Time Frame: Day 1
Number, location and severity of any pedicle breaches
Day 1
Adverse Event Rate & Serious Adverse Events
Time Frame: Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks
Measured intra-operatively and post-operatively
Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks
Guide Reliability
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10079 (Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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