Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical Trial
ABSTRACT Objective The 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...
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| Format: | Article |
| Language: | English |
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Wiley
2025-02-01
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| Series: | Orthopaedic Surgery |
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| Online Access: | https://doi.org/10.1111/os.14295 |
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| author | Yichao Ma Jiangpeng Wu Yanlong Dong Hongmei Tang Xiaojun Ma |
| author_facet | Yichao Ma Jiangpeng Wu Yanlong Dong Hongmei Tang Xiaojun Ma |
| author_sort | Yichao Ma |
| collection | DOAJ |
| description | ABSTRACT Objective The 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. Methods A 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. Results In 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. Conclusions The AR surgical navigation system can improve the accuracy of pedicle screw implantation and provide precise guidance for surgeons during pedicle screw insertion. |
| format | Article |
| id | doaj-art-71601e5f22414caba82560a6416d1987 |
| institution | Kabale University |
| issn | 1757-7853 1757-7861 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Orthopaedic Surgery |
| spelling | doaj-art-71601e5f22414caba82560a6416d19872025-02-03T03:10:59ZengWileyOrthopaedic Surgery1757-78531757-78612025-02-0117263164310.1111/os.14295Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical TrialYichao Ma0Jiangpeng Wu1Yanlong Dong2Hongmei Tang3Xiaojun Ma4Shanghai University of Traditional Chinese Medicine Shanghai ChinaDepartment of Orthopedics, Shanghai General Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaLinyan Medical Technology Company Limited Shanghai ChinaShanghai University of Traditional Chinese Medicine Shanghai ChinaDepartment of Orthopedics, Shanghai General Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaABSTRACT Objective The 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. Methods A 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. Results In 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. Conclusions The AR surgical navigation system can improve the accuracy of pedicle screw implantation and provide precise guidance for surgeons during pedicle screw insertion.https://doi.org/10.1111/os.14295accuracyaugmented realitynavigationpedicle screwthoracolumbar spine |
| spellingShingle | Yichao Ma Jiangpeng Wu Yanlong Dong Hongmei Tang Xiaojun Ma Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical Trial Orthopaedic Surgery accuracy augmented reality navigation pedicle screw thoracolumbar spine |
| title | Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical Trial |
| title_full | Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical Trial |
| title_fullStr | Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical Trial |
| title_full_unstemmed | Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical Trial |
| title_short | Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel‐Controlled Clinical Trial |
| title_sort | augmented reality navigation system enhances the accuracy of spinal surgery pedicle screw placement a randomized multicenter parallel controlled clinical trial |
| topic | accuracy augmented reality navigation pedicle screw thoracolumbar spine |
| url | https://doi.org/10.1111/os.14295 |
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