ScoliosisSPINAVNCT05107310
The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery
A study testing Pedicle screws insertion by free hand technique, Pedicle screws insertion using ARSN and Pedicle screws insertion using IRSN in people with Scoliosis and Kyphosis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- Pedicle screws insertion by free hand technique, Pedicle screws insertion using ARSN and Pedicle screws insertion using IRSN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSweden
- Study dates
- 18 Jan 2022to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent by patient or legal guardian
- Age 12 years and older
- Spinal deformity surgery
Who cannot join
- Unable to give informed consent
- Surgery without pedicle screws
- Previous surgery with pedicle screws in the planned surgical area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SpiNav - SPInal NAVigation Trial
The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity
Read the detailed description
Spinal deformity is a common reason for spinal surgery at youth. In addition, the incidence of surgery for spinal deformity in older adults is increasing. Spinal deformity surgery is by far the most complex spine surgery. One complexity lies in the correct placement of implants in the severely deformed spine. Today, the most common surgical procedures for spinal deformity involve placement of screws in the vertebral pedicle in the instrumented part of the spine. This gives good bone purchase, which is important for deformity correction.
The pedicle is narrow and misplaced pedicle screws can result in vascular, pulmonary or neural injuries, or inadequate bone purchase. Compared to the conventional free-hand surgical technique, which relies on the knowledge of anatomy, computer-assisted navigation using intraoperative 3D imaging has been shown to improve screw placement accuracy and reduce complications due to screw misplacements. As a consequence, navigation may also reduce the frequency of postoperative revision surgery compared to free hand. However, navigation still takes time, and is associated with higher intraoperative radiation than the free hand technique.
As of yet, the majority of data in this area are based on retrospectively collected series, and some prospectively collected series, while randomized controlled trials on spinal deformity are lacking.
In this randomized controlled trial the accuracy of pedicle screw placement using augmented reality surgical navigation (ARSN), infra-red surgical navigation (IRSN) and conventional free-hand technique will be investigated.
Patients of age 12 years and older with spinal deformities are randomized into one of the three surgical techniques mentioned above.
The primary outcome variable is pedicle screw placement accuracy at 1st attempt assessed using the Gertzbein scale.
Data from the navigated groups (ASRN and IRSN) will be analyzed together, and compared with the free hand groups analyzed together. The ASRN and ISRN groups will also be compared with their respective free hand groups.
- Being tested
- Pedicle screws insertion by free hand technique, Pedicle screws insertion using ARSN, Pedicle screws insertion using IRSN
- Medical subject headings
- Scoliosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicle screws insertion by free hand techniqueProcedure or surgery
Spinal deformity correction. Pedicle screws are inserted using free hand technique with the help of intraoperative fluoroscopy if needed.
Pedicle screws insertion using ARSNProcedure or surgery
Spinal deformity correction. Pedicle screws are inserted using augmented reality surgical navigation (ARSN) with the ClarifEye navigation system and the Philips Allura 2D/3D imaging system.
Pedicle screws insertion using IRSNProcedure or surgery
Spinal deformity correction. Pedicle screws are inserted using infra-red surgical navigation (IRSN) with the Brainlab Curve 1.2 navigation system combined with the Medtronic O-arm 2D/3D imaging system.
| Study group | Role | What they receive |
|---|---|---|
| Navigation group 1 ARSN | Experimental | Augmented reality surgical navigation (ARSN). Pedicle screw placement using the Philips ClarifEye system combined with Philips Allura for imaging. Receives: Procedure: Pedicle screws insertion using ARSN |
| Control group 1 FH | Active comparator | Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique. Receives: Procedure: Pedicle screws insertion by free hand technique |
| Navigation group 2 IRSN | Experimental | Infrared surgical navigation (IRSN). Pedicle screw placement using Brainlab Curve 1.2 combined with Medtronic o-arm for imaging. Receives: Procedure: Pedicle screws insertion using IRSN |
| Control group 2 FH | Active comparator | Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique. Receives: Procedure: Pedicle screws insertion by free hand technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurately placed pedicle screws
The primary endpoint is the percentage of accurately placed pedicle screws assessed using the Gertzbein scale and based on intraoperative verification scan cone beam computed tomography (CBCT).
Measured: Intraoperative
Secondary outcomes (29)
Pedicle screw intraoperative revision rates-clinical assessment
Number of screws intraoperatively revised based on clinical assessment
Measured: Intraoperative
Pedicle screw intraoperative revision rates- neurophysiology
Number of screws intraoperatively revised based on neurophysiology
Measured: Intraoperative
Pedicle screw intraoperative revision rates- intraoperative verification
Number of screws intraoperatively revised based on intraoperative verification CBCT scan
Measured: Intraoperative
Accuracy for ARSN - path deviation in mm
Deviation from planned navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)
Measured: Intraoperative
Accuracy for IRSN- path deviation in mm
Deviation from navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)
Measured: Intraoperative
Accuracy for ARSN - angular deviation
Angular deviation (degrees) of the placed screw compared to the planned navigated path measured on the postoperative computed tomography (CT)
Measured: Intraoperative
Accuracy for IRSN - angular deviation
Angular deviation of the placed screw compared to the navigated path measured on the postoperative computed tomography (CT)
Measured: Intraoperative
Accuracy at 1st attempt
Accuracy at 1st attempt = (Screws placed at first attempt according to intraoperative protocols and graded 0 or 1) / (total number of placed screws).
Assessed on intraoperative CBCT
Measured: Intraoperative
Final accuracy of placed pedicle screws
Final accuracy of placed pedicle screws is calculated as: number of accurately placed screws (Gertzbein grade 0+1) according to postoperative CT / total number of placed screws.
Measured: Intraoperative
Pedicle screw placement density
The study aims for 100% pedicle screw density. Hooks may be placed as rescue or if screw placement fails.
Measured: Intraoperative
Pedicle screw placement in relation to morphometric measurements
Pedicle diameters are measured on preoperative and intraoperative CT. Pedicle screw placement measured on intraoperative and postoperative CT.
Measured: Preoperative and intraoperative
Deformity correction change
Cobb angle change from preoperative to first erect postoperative radiograph
Measured: 3-6 months post-op
Patient radiation dose exposure
Patient radiation exposure (ED in mSv) for the whole procedure, Patient radiation exposure (ED in mSv) for fluoroscopy Patient radiation exposure (ED in mSv) for each CBCT
Measured: Intraoperative
Staff radiation dose exposure
Average staff radiation exposure (in mSv) for the whole procedure
Measured: Intraoperative
Intraoperative characteristics- procedure time
Total procedure time as well as normalized to number of spinal levels from the upper to the lower instrumented vertebra.
Measured: Intraoperative
Intraoperative characteristics- planning time
Intraoperative planning time (from start of planning in navigation software until last screw planned) (only when treated with ARSN or IRSN)
Measured: Intraoperative
Intraoperative characteristics- instrumentation time
Instrumentation time (total time for navigated/FH screw placement from first to last screw placement)
Measured: Intraoperative
Intraoperative characteristics- instrumentation time/level
Instrumentation time normalized to number of levels
Measured: Intraoperative
Intraoperative characteristics- time for verification imaging
Time for intraoperative verification imaging (CBCT and/or Fluoroscopy)
Measured: Intraoperative
Intraoperative characteristics- screw placement time
Screw placement time (per screw, from start with awl to screw placed)
Measured: Intraoperative
Intraoperative characteristics- blood loss
Intraoperative blood loss
Measured: Intraoperative
Inpatient stay
Length of hospital stay in days
Measured: Measured from day of surgery until day of discharge. Usual length of stay is less than one week, and maximum two weeks.
Patient reported outcome measures- Scoliosis Research Society 22 revised (SRS-22r)
The scoliosis specific questionnaire SRS-22r ranging from 1 (worst) to 5 (best)
Measured: up to 5 years
Patient reported outcome measures- the 24 item Early Onset Scoliosis Questionnaire (EOSQ-24)
The scoliosis specific questionnaire EOSQ-24 ranging from 0 (worst) to 100 (best)
Measured: up to 5 years
Patient reported outcome measures- Oswestry Disability Index (ODI)
The back disabiliy questionnaire (ODI) ranging from 0 (best) to 100 (worst)
Measured: up to 5 years
Patient reported outcome measures- EQ-5D 3 level version (EQ-5D-3L)
The generic quality of life EQ-5D-3L index ranging from -0.59 (worst) to 1.00 (best)
Measured: up to 5 years
Complications
Number of patients that have had complications
Measured: At 30 days, at 90 days
Revision surgery
Number of patients that have undergone revision surgeries
Measured: At 30 days, at 90 days, at 1 year
Cost per patient
Cost per patient
Measured: At 30 days, at 90 days, at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start18 Jan 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Uppsala University
- Responsible party
- Principal investigator, Paul Gerdhem, Uppsala University
- Investigators
- Paul Gerdhem, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107310
- Sponsor's protocol ID
- SPINAV
- Acronym
- SPINAV
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2021
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Manuscripts will be submitted for publication in peer-reviewed journals. Quality-controlled raw data as well as processed data used in publications will be made available at the time of publication.
Publications
El-Hajj VG, Charalampidis A, Fell D, Edstrom E, Elmi-Terander A, Gerdhem P. Study protocol: the SPInal NAVigation (SPINAV) trial - comparison of augmented reality surgical navigation, conventional image-guided navigation, and free-hand technique for pedicle screw placement in spinal deformity surgery. BMC Musculoskelet Disord. 2025 Jun 2;26(1):543. doi: 10.1186/s12891-025-08817-3.
PubMed 40457280
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpiNav - SPInal NAVigation Trial
- ClinicalTrials.gov ID
- NCT05107310
- Acronym / sponsor ID
- SPINAV / SPINAV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Uppsala University
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 4 Nov 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.
The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity
Detailed description
Spinal deformity is a common reason for spinal surgery at youth. In addition, the incidence of surgery for spinal deformity in older adults is increasing. Spinal deformity surgery is by far the most complex spine surgery. One complexity lies in the correct placement of implants in the severely deformed spine. Today, the most common surgical procedures for spinal deformity involve placement of screws in the vertebral pedicle in the instrumented part of the spine. This gives good bone purchase, which is important for deformity correction.
The pedicle is narrow and misplaced pedicle screws can result in vascular, pulmonary or neural injuries, or inadequate bone purchase. Compared to the conventional free-hand surgical technique, which relies on the knowledge of anatomy, computer-assisted navigation using intraoperative 3D imaging has been shown to improve screw placement accuracy and reduce complications due to screw misplacements. As a consequence, navigation may also reduce the frequency of postoperative revision surgery compared to free hand. However, navigation still takes time, and is associated with higher intraoperative radiation than the free hand technique.
As of yet, the majority of data in this area are based on retrospectively collected series, and some prospectively collected series, while randomized controlled trials on spinal deformity are lacking.
In this randomized controlled trial the accuracy of pedicle screw placement using augmented reality surgical navigation (ARSN), infra-red surgical navigation (IRSN) and conventional free-hand technique will be investigated.
Patients of age 12 years and older with spinal deformities are randomized into one of the three surgical techniques mentioned above.
The primary outcome variable is pedicle screw placement accuracy at 1st attempt assessed using the Gertzbein scale.
Data from the navigated groups (ASRN and IRSN) will be analyzed together, and compared with the free hand groups analyzed together. The ASRN and ISRN groups will also be compared with their respective free hand groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Navigation group 1 ARSN | Experimental | Procedure: Pedicle screws insertion using ARSNAugmented reality surgical navigation (ARSN). Pedicle screw placement using the Philips ClarifEye system combined with Philips Allura for imaging. |
| Control group 1 FH | Active comparator | Procedure: Pedicle screws insertion by free hand techniqueFree hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique. |
| Navigation group 2 IRSN | Experimental | Procedure: Pedicle screws insertion using IRSNInfrared surgical navigation (IRSN). Pedicle screw placement using Brainlab Curve 1.2 combined with Medtronic o-arm for imaging. |
| Control group 2 FH | Active comparator | Procedure: Pedicle screws insertion by free hand techniqueFree hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent by patient or legal guardian
- Age 12 years and older
- Spinal deformity surgery
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Surgery without pedicle screws
- Previous surgery with pedicle screws in the planned surgical area
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 |
|---|---|---|
| Pedicle screws insertion by free hand techniqueSpinal deformity correction. Pedicle screws are inserted using free hand technique with the help of intraoperative fluoroscopy if needed. | Procedure or surgery | Control group 1 FH, Control group 2 FH |
| Pedicle screws insertion using ARSNSpinal deformity correction. Pedicle screws are inserted using augmented reality surgical navigation (ARSN) with the ClarifEye navigation system and the Philips Allura 2D/3D imaging system. | Procedure or surgery | Navigation group 1 ARSN |
| Pedicle screws insertion using IRSNSpinal deformity correction. Pedicle screws are inserted using infra-red surgical navigation (IRSN) with the Brainlab Curve 1.2 navigation system combined with the Medtronic O-arm 2D/3D imaging system. | Procedure or surgery | Navigation group 2 IRSN |
Primary outcome
Accurately placed pedicle screws
Time frame: Intraoperative
The primary endpoint is the percentage of accurately placed pedicle screws assessed using the Gertzbein scale and based on intraoperative verification scan cone beam computed tomography (CBCT).
29 secondary outcomes
Pedicle screw intraoperative revision rates-clinical assessment
Time frame: Intraoperative
Pedicle screw intraoperative revision rates- neurophysiology
Time frame: Intraoperative
Pedicle screw intraoperative revision rates- intraoperative verification
Time frame: Intraoperative
Accuracy for ARSN - path deviation in mm
Time frame: Intraoperative
Accuracy for IRSN- path deviation in mm
Time frame: Intraoperative
Accuracy for ARSN - angular deviation
Time frame: Intraoperative
Accuracy for IRSN - angular deviation
Time frame: Intraoperative
Accuracy at 1st attempt
Time frame: Intraoperative
Final accuracy of placed pedicle screws
Time frame: Intraoperative
Pedicle screw placement density
Time frame: Intraoperative
Pedicle screw placement in relation to morphometric measurements
Time frame: Preoperative and intraoperative
Deformity correction change
Time frame: 3-6 months post-op
Patient radiation dose exposure
Time frame: Intraoperative
Staff radiation dose exposure
Time frame: Intraoperative
Intraoperative characteristics- procedure time
Time frame: Intraoperative
Intraoperative characteristics- planning time
Time frame: Intraoperative
Intraoperative characteristics- instrumentation time
Time frame: Intraoperative
Intraoperative characteristics- instrumentation time/level
Time frame: Intraoperative
Intraoperative characteristics- time for verification imaging
Time frame: Intraoperative
Intraoperative characteristics- screw placement time
Time frame: Intraoperative
Intraoperative characteristics- blood loss
Time frame: Intraoperative
Inpatient stay
Time frame: Measured from day of surgery until day of discharge. Usual length of stay is less than one week, and maximum two weeks.
Patient reported outcome measures- Scoliosis Research Society 22 revised (SRS-22r)
Time frame: up to 5 years
Patient reported outcome measures- the 24 item Early Onset Scoliosis Questionnaire (EOSQ-24)
Time frame: up to 5 years
Patient reported outcome measures- Oswestry Disability Index (ODI)
Time frame: up to 5 years
Patient reported outcome measures- EQ-5D 3 level version (EQ-5D-3L)
Time frame: up to 5 years
Complications
Time frame: At 30 days, at 90 days
Revision surgery
Time frame: At 30 days, at 90 days, at 1 year
Cost per patient
Time frame: At 30 days, at 90 days, at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 40457280El-Hajj VG, Charalampidis A, Fell D, Edstrom E, Elmi-Terander A, Gerdhem P. Study protocol: the SPInal NAVigation (SPINAV) trial - comparison of augmented reality surgical navigation, conventional image-guided navigation, and free-hand technique for pedicle screw placement in spinal deformity surgery. BMC Musculoskelet Disord. 2025 Jun 2;26(1):543. doi: 10.1186/s12891-025-08817-3.
- Individual participant dataSharing planned: Yes. Manuscripts will be submitted for publication in peer-reviewed journals. Quality-controlled raw data as well as processed data used in publications will be made available at the time of publication.
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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.
Paul Gerdhem, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedicle screws insertion by free hand technique, Pedicle screws insertion using ARSN and Pedicle screws insertion using IRSN in people with Scoliosis and Kyphosis, run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accurately placed pedicle screws (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05107310, which also lists 1 linked publication.
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 27 Aug 2026.