Evidence map›Paper›PMID 40457280›Full record

ArticleBMC musculoskeletal disorders2025

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.

Victor Gabriel El-Hajj, Anastasios Charalampidis, Daniel Fell, Erik Edström, Adrian Elmi-Terander, Paul Gerdhem

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05107310 (SpiNav - SPInal NAVigation Trial), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05107310 naactive not recruitingnot on this map

SpiNav - SPInal NAVigation Trial

TypeinterventionalSponsorKarolinska InstitutetRan2022 to 2029Enrolled62ConditionsScoliosis, KyphosisArmsPedicle screws insertion by free hand technique, Pedicle screws insertion using ARSN, Pedicle screws insertion using IRSN
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Victor Gabriel El-HajjDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Anastasios CharalampidisDepartment of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.
Daniel FellCapio Stockholm Spine Center, Löwenströmska Hospital, Box 2074, Stockholm, Upplands-Väsby, 194 02, Sweden.
Erik EdströmDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Adrian Elmi-TeranderDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Adrian.elmi.terander@ki.se.
Paul GerdhemDepartment of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeAlthough 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

methodsThis 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 registrationThe trial is registered at clinicaltrials.gov (NCT05107310) on 2021-11-03.

Indexed as

Augmented RealityPedicle ScrewsSpinal FusionSurgery, Computer-AssistedCone-Beam Computed TomographyFemaleHumansMaleRandomized Controlled Trials as TopicAugmented realityNavigationPedicle screwsSpinal instrumentation

Identifiers

PMID40457280
PMCPMC12131368

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.