SurgeryHoloNaviNCT04610411
Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality
A study testing surgical navigation and standard surgical method in people with Surgery, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
This study will investigate the accuracy of implant navigation for spinal instrumentation. The tested technique is based on commercially available AR-glasses and a specially developed software component Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- surgical navigation and standard surgical method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2020to 12 Apr 2024
- 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
- Indication for surgical instrumentation of the spine (Os Sacrum, L1-L5, Th1-Th12) without or with correction of a malposition.
- Anatomical adaptation of the rod implant necessary.
- The trial participant is able to give his/her consent.
- Signed written declaration of consent after oral and written explanation.
- Male and female patients aged 18 years and older.
- Indication for a preoperative CT scan of the lumbar spine
- Existence of a preoperative planning, which was created on the basis of 3D CT imaging
Who cannot join
- Pregnant or breastfeeding women
- Emergency situations
- Other known clinically significant concomitant diseases (e.g. infections, tumors, co-existing arthrosis).
- Known or suspected incompliance with the protocol, such as drug or alcohol abuse.
- Inability of the patient to follow the study procedures, e.g., due to language problems, mental illness, dementia, etc.
- There is no conventional surgical treatment that can be used if the MP cannot be used intraoperatively.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
This study will investigate the accuracy of implant navigation for spinal instrumentation. The tested technique is based on commercially available AR-glasses and a specially developed software component
Read the detailed description
The experimental intervention consists of using the AR-glasses and a specially developed software as a navigation aid in surgery. The surgical technique for the intervention group corresponds to the established standard method. It is identical to the control intervention except for the step where pedicle screws or rod implants are instrumented.
The surgeon wears the hardware component during the entire surgery. He proceeds conventionally up to the point where navigation of pedicle screws and rod implants with is required.
- Conditions
- Surgery
- Being tested
- surgical navigation, standard surgical method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical navigationDevice
surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software
standard surgical methodOther
standard surgical method established at the institution
| Study group | Role | What they receive |
|---|---|---|
| surgical navigation | Experimental | standard surgical method except for navigated instrumentation of pedicle screws and rod implants Receives: Device: surgical navigation |
| standard surgical method | Active comparator | standard surgical method established at the institution Receives: Other: standard surgical method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging
Measured: within 7 days of surgery
Accuracy
3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging
Measured: within 7 days of surgery
Secondary outcomes (8)
Number of rod bending attempts
bending attempts are counted during surgery
Measured: during surgery
Number of length corrections of rod implant
required length corrections are counted during surgery
Measured: during surgery
time needed for pedicle screw implantation
time is measured during surgery
Measured: during surgery
surgery duration
total Duration of surgery
Measured: during surgery
Radiation dose during surgery
total radiation dose applied during surgery
Measured: during surgery
Usability
measuring of surgeon satisfaction using visual analogue scale from a minimum of 0 to a maximum of 10
Measured: within 7 days of surgery
Clinical Outcome Pain
Standardized clinical pain score (visual analogue scale for pain with 0=no pain and 10=unbearable pain) is routinely evaluated before surgery and in the follow up
Measured: up to 1 year of surgery
Clinical Outcome Disability
Standardized clinical disability score (Oswestry Low Back Pain Questionnaire with 0%=minimal disability and 100%=maximal disability ) is routinely evaluated before surgery and in the follow up
Measured: up to 1 year of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Nov 2020
- Primary completion11 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazda Farshad, Prof., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610411
- Sponsor's protocol ID
- HoloNavigation
- Acronym
- HoloNavi
- Status last verified
- Feb 2023
- First submitted
- 8 Jun 2020
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality
- ClinicalTrials.gov ID
- NCT04610411
- Acronym / sponsor ID
- HoloNavi / HoloNavigation
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 30 Oct 2020 (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 study will investigate the accuracy of implant navigation for spinal instrumentation. The tested technique is based on commercially available AR-glasses and a specially developed software component
Detailed description
The experimental intervention consists of using the AR-glasses and a specially developed software as a navigation aid in surgery. The surgical technique for the intervention group corresponds to the established standard method. It is identical to the control intervention except for the step where pedicle screws or rod implants are instrumented.
The surgeon wears the hardware component during the entire surgery. He proceeds conventionally up to the point where navigation of pedicle screws and rod implants with is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical navigation | Experimental | Device: surgical navigationstandard surgical method except for navigated instrumentation of pedicle screws and rod implants |
| standard surgical method | Active comparator | Other: standard surgical methodstandard surgical method established at the institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Indication for surgical instrumentation of the spine (Os Sacrum, L1-L5, Th1-Th12) without or with correction of a malposition.
- Anatomical adaptation of the rod implant necessary.
- The trial participant is able to give his/her consent.
- Signed written declaration of consent after oral and written explanation.
- Male and female patients aged 18 years and older.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Emergency situations
- Other known clinically significant concomitant diseases (e.g. infections, tumors, co-existing arthrosis).
- Known or suspected incompliance with the protocol, such as drug or alcohol abuse.
- Inability of the patient to follow the study procedures, e.g., due to language problems, mental illness, dementia, etc.
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 |
|---|---|---|
| surgical navigationsurgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software | Device | surgical navigation |
| standard surgical methodstandard surgical method established at the institution | Other | standard surgical method |
Primary outcome
Accuracy
Time frame: within 7 days of surgery
3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging
Accuracy
Time frame: within 7 days of surgery
3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging
8 secondary outcomes
Number of rod bending attempts
Time frame: during surgery
Number of length corrections of rod implant
Time frame: during surgery
time needed for pedicle screw implantation
Time frame: during surgery
surgery duration
Time frame: during surgery
Radiation dose during surgery
Time frame: during surgery
Usability
Time frame: within 7 days of surgery
Clinical Outcome Pain
Time frame: up to 1 year of surgery
Clinical Outcome Disability
Time frame: up to 1 year of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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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.
Mazda Farshad, Prof. principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical navigation and standard surgical method in people with Surgery, run by Balgrist University Hospital at 1 site in Switzerland.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy (time frame: within 7 days of surgery). 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 31 May 2024.