The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery
SPINAV
SpiNav - SPInal NAVigation Trial
1 other identifier
interventional
62
1 country
1
Brief Summary
The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedFirst Posted
Study publicly available on registry
November 4, 2021
CompletedStudy Start
First participant enrolled
January 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
ExpectedFebruary 21, 2025
February 1, 2025
2.4 years
September 14, 2021
February 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Intraoperative
Secondary Outcomes (29)
Pedicle screw intraoperative revision rates-clinical assessment
Intraoperative
Pedicle screw intraoperative revision rates- neurophysiology
Intraoperative
Pedicle screw intraoperative revision rates- intraoperative verification
Intraoperative
Accuracy for ARSN - path deviation in mm
Intraoperative
Accuracy for IRSN- path deviation in mm
Intraoperative
- +24 more secondary outcomes
Study Arms (4)
Navigation group 1 ARSN
EXPERIMENTALAugmented reality surgical navigation (ARSN). Pedicle screw placement using the Philips ClarifEye system combined with Philips Allura for imaging.
Control group 1 FH
ACTIVE COMPARATORFree hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique.
Navigation group 2 IRSN
EXPERIMENTALInfrared surgical navigation (IRSN). Pedicle screw placement using Brainlab Curve 1.2 combined with Medtronic o-arm for imaging.
Control group 2 FH
ACTIVE COMPARATORFree hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique.
Interventions
Spinal deformity correction. Pedicle screws are inserted using free hand technique with the help of intraoperative fluoroscopy if needed.
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.
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.
Eligibility Criteria
You may qualify if:
- Written informed consent by patient or legal guardian
- Age 12 years and older
- Spinal deformity surgery
You may not qualify if:
- Unable to give informed consent
- Surgery without pedicle screws
- Previous surgery with pedicle screws in the planned surgical area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
- Uppsala Universitycollaborator
Study Sites (1)
Karolinska University Hospital
Stockholm, 14186, Sweden
Related Publications (1)
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.
PMID: 40457280DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Gerdhem, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 14, 2021
First Posted
November 4, 2021
Study Start
January 18, 2022
Primary Completion
June 30, 2024
Study Completion (Estimated)
June 30, 2029
Last Updated
February 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The detailed protocol, including the statistical analysis plan will be submitted for publication after study start. No end date.
- Access Criteria
- Either as an appendix to publications, or at a repository at the Sponsor of the trial.
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.