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The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery
Sponsor: Karolinska Institutet
Summary
The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity
Official title: SpiNav - SPInal NAVigation Trial
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2022-01-18
Completion Date
2029-06-30
Last Updated
2025-02-21
Healthy Volunteers
No
Interventions
Pedicle screws insertion by free hand technique
Spinal deformity correction. Pedicle screws are inserted using free hand technique with the help of intraoperative fluoroscopy if needed.
Pedicle screws insertion using ARSN
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 IRSN
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.
Locations (1)
Karolinska University Hospital
Stockholm, Sweden