Orthopedic Disorder of SpineNCT04751981
Safety Trial of Patient Specific Guides for Lumbar Fusion
A study testing Patient Specific Guide and Navigation in people with Orthopedic Disorder of Spine, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder of Spine
- What is being tested?
- Patient Specific Guide and Navigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Orthopedic Disorder of Spine
- Being tested
- Patient Specific Guide, Navigation
- Keywords
- Patient Specific Guides, Lumbar Fusion, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Specific GuideProcedure or surgery
For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
NavigationProcedure or surgery
Conventional navigation will be used to place pedicle screws.
| Study group | Role | What they receive |
|---|---|---|
| Patient Specific Guide | Experimental | Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides. Receives: Procedure: Patient Specific Guide |
| Navigation | Other | Patients randomized into this group will have pedicle screws placed with conventional navigation. Receives: Procedure: Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screw trajectory deviation
Measured as the angle in degrees deviated from the planned trajectory
Measured: Day 1
Screw start point deviation
Measured as distance in millimeters from the planed start point.
Measured: Day 1
Secondary outcomes (3)
Pedicle Breach
Number, location and severity of any pedicle breaches
Measured: Day 1
Adverse Event Rate & Serious Adverse Events
Measured intra-operatively and post-operatively
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Disorder of SpineStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751981
- Sponsor's protocol ID
- 10079
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Trial for Evaluating Patient Specific Guides Accuracy for Pedicle Screw Insertion in Lumbar Fusion
- ClinicalTrials.gov ID
- NCT04751981
- Acronym / sponsor ID
- 10079
- Conditions
- Orthopedic Disorder of Spine
- Keywords
- Patient Specific Guides, Lumbar Fusion, Spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Specific Guide | Experimental | Procedure: Patient Specific GuidePatients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides. |
| Navigation | Other | Procedure: NavigationPatients randomized into this group will have pedicle screws placed with conventional navigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Specific GuideFor lumbar fusion pedicle screws will be placed with the aid of patient specific guides. | Procedure or surgery | Patient Specific Guide |
| NavigationConventional navigation will be used to place pedicle screws. | Procedure or surgery | Navigation |
Primary outcome
Screw trajectory deviation
Time frame: Day 1
Measured as the angle in degrees deviated from the planned trajectory
Screw start point deviation
Time frame: Day 1
Measured as distance in millimeters from the planed start point.
3 secondary outcomes
Pedicle Breach
Time frame: Day 1
Adverse Event Rate & Serious Adverse Events
Time frame: Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks
Guide Reliability
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Specific Guide and Navigation in people with Orthopedic Disorder of Spine, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screw trajectory deviation (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.