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.

BACKGROUND AND PURPOSE: Although navigation is increasingly used in spinal surgery, the advantage of different navigation technologies is still a matter of debate. Conventional image-guided navigation is currently the gold standard. However, modern, Augmented reality-based navigation methods are increasingly gaining ground. Surgical navigation in deformity surgery allows placement of pedicle screws in small and deformed pedicles and may result in both a higher accuracy and density of pedicle screw placement. The aim of this trial is to compare AR and conventional surgical navigation to free-hand technique.

PATIENTS AND

METHODS

This is a single center, open label, parallel assignment, three arm, randomized, controlled trial, comparing: Augmented reality surgical navigation (ARSN), Infrared surgical navigation (IRSN) and Free-hand (FH) technique. Individuals scheduled for spinal deformity surgery are eligible for inclusion. The inclusion criteria are written informed consent, age ≥ 12 years and spinal deformity. Subjects will be randomized intraoperatively and strictly sequentially.

OUTCOMES: The primary endpoint is accurately placed pedicle screws based on intraoperative verification cone beam computed tomography (CBCT) scan. All radiological image analyses, on both intra- and postoperative imaging will be performed postoperatively by blinded reviewers. Several secondary outcome measures including revision rate, radiation exposure, implant density and final accuracy will be analyzed. Patient reported outcomes will also be assessed. Finally, a cost-benefit analysis will be performed.

START OF TRIAL AND ESTIMATED DURATION: The SPINAV trial started recruiting patients in January 2022 and will continue for approximately 2.5 years.

TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (NCT05107310) on 2021-11-03.