Evidence map›Paper›PMID 39815419›Full record

Trial reportOrthopaedic surgery2025

Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel-Controlled Clinical Trial.

Yichao Ma, Jiangpeng Wu, Yanlong Dong, Hongmei Tang, Xiaojun Ma

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Orthopaedic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Evaluation of a mixed reality navigation simulator for training of minimally invasive interventions of the spine: a pilot didactic plan.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
    Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Intraoperative Navigation in Cervical Spine Surgery.Journal of clinical medicine · 2026
    Review
  11. A Mixed-Reality Navigation Simulator for Training Infiltration Procedures of the Spine: Evaluation in Kambin Triangle Location.The international journal of medical robotics + computer assisted surgery : MRCAS · 2026
    Article
  12. Review
  13. Article
  14. Review
  15. Article
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  18. Review
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

5 authors.

Yichao MaShanghai University of Traditional Chinese Medicine, Shanghai, China.
Jiangpeng WuDepartment of Orthopedics, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yanlong DongLinyan Medical Technology Company Limited, Shanghai, China.
Hongmei TangShanghai University of Traditional Chinese Medicine, Shanghai, China.
Xiaojun MaDepartment of Orthopedics, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID https://orcid.org/0000-0002-0663-1159

Funding

National Natural Science Foundation of China 82072969National Natural Science Foundation of China 82373447
6 · The paper itself

Abstract

objectiveThe pedicle screw insertion technique has evolved significantly, and despite the challenges of precise placement, advancements like AR-based surgical navigation systems now offer enhanced accuracy and safety in spinal surgery by integrating real-time, high-resolution imaging with virtual models to aid surgeons. This study aims to evaluate the differences in accuracy between novel AR-guided pedicle screw insertion and conventional surgery techniques.

methodsA randomized controlled trial was conducted from March 2019 to December 2023 to compare the efficacy of AR-guided pedicle screw fixation with conventional freehand surgery using CT guidance. The study included 150 patients, aged 18-75, with 75 patients in each group. The total number of pedicle screws planned for the clinical trial placement was 351 and 348 in the experimental and control groups. The safety and efficacy of the procedures were evaluated by assessing screw placement accuracy and complication rates.

resultsIn the full analysis set (FAS) analysis, the difference in the excellent and good rates of screw placement (experimental group - control group) and 95% confidence interval was 6.3% [3.0%-9.8%], with a p value of 0.0003 for the superiority test. In the FAS sensitivity analysis, the success rate was 98.0% (344 out of 351) in the experimental group and 91.7% (319 out of 348) in the control group, with a difference and 95% confidence interval of 6.3% [2.9% and 9.8%, respectively]. In the per-protocol set (PPS) analysis, the difference in the excellent and good rates of screw placement between the experimental and control groups, and the 95% confidence interval was 6.4% [3.3%-9.5%], with a p value of 0.0001 for the superiority test. In the actual treatment set (ATS) analysis, the excellent and good rates of screw placement were 99.1% in the experimental group and 91.7% in the control group. The difference in the excellent and good rates of screw placement (experimental group - control group) and 95% confidence interval was 7.3% [4.1%-10.6%], with a p value of < 0.0001 for the superiority test.

conclusionsThe AR surgical navigation system can improve the accuracy of pedicle screw implantation and provide precise guidance for surgeons during pedicle screw insertion.

Indexed as

Augmented RealityPedicle ScrewsSpinal FusionSurgery, Computer-AssistedSurgical Navigation SystemsAdolescentAdultAgedFemaleHumansMaleMiddle AgedYoung Adultaccuracyaugmented realitynavigationpedicle screwthoracolumbar spine

Identifiers

PMID39815419
PMCPMC11787979

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Registered trials

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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.