通过新型定制器械扩展机器人辅助胸腰椎手术的植入物选择

IF 1.5 Q3 ORTHOPEDICS

Journal of orthopaedics Pub Date : 2025-08-18 DOI:10.1016/j.jor.2025.08.031

Abhishek Soni , Vidyadhara S , Balamurugan T , Alia Vidyadhara

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引用次数: 0

摘要

背景：与传统技术相比，机器人辅助椎弓根螺钉置入具有更高的准确性，但专有的生态系统限制了植入物的兼容性和手术选择。在Mazor X隐形版机器人系统中，定制螺丝刀是否可以在保持导航精度的同时启用第三方仪表？方法本回顾性比较单中心研究分析了100例使用定制螺丝刀器械进行机器人辅助胸腰椎融合的患者（2024年7月至12月）和100例使用标准专有器械的历史对照组（2010月至2024年6月）。定制螺丝刀的轴尺寸与机械臂导轨和导航跟踪器兼容。主要结果包括采用Gertzbein-Robbins分类的椎弓根螺钉放置准确性和技术可行性。结果自定义螺丝刀组共放置708枚螺钉，对照组为760枚。临床可接受的螺钉置入（Gertzbein-Robbins分级a和B）分别为99.15%（702/708）和99.07%(753/760)（差异：0.08%,95% CI: 1.14% - 1.30%, p = 0.880）。非劣效性证明，较低的置信区间（- 1.14%）超过了预定义的边际（- 3%）。技术可行性为100%，不需要转换。手术时间（142.3±38.5 vs 148.7±40.2 min, p = 0.239）、出血量（537.2±328.0 vs 550.0±359.0 ml, p = 0.793）、螺钉放置时间（6.2±1.8 vs 6.4±1.7 min, p = 0.426）具有可比性。定制螺丝起子组种植体成本显著降低（559.50±224.35美元vs 1973.47±934.80美元，p < 0.001）。结论自定义器械设计成功地保持了手术精度，同时使第三方植入物集成到机器人脊柱手术工作流程中。这种方法证明了机器人系统模块化的增强，而不影响准确性，安全性或操作效率。临床相关性：这项创新使外科医生能够根据临床证据而不是专利限制选择最佳植入物，通过增强系统灵活性，潜在地改善患者的治疗效果，同时降低医疗成本。证据水平ii。

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Expanding implant options in robot-assisted thoracolumbar spine surgery through novel customized instrumentation

Background

Robot-assisted pedicle screw placement demonstrates superior accuracy over conventional techniques, yet proprietary ecosystems limit implant compatibility and surgical choice. Can a custom screwdriver enable third-party instrumentation while maintaining navigational precision within the Mazor X Stealth Edition robotic system?

Methods

This retrospective comparative single-center study analysed 100 consecutive patients undergoing robot-assisted thoracolumbar fusion using custom screwdriver instrumentation (July–December 2024) versus 100 historical controls using standard proprietary instrumentation (October 2023–June 2024). The custom screwdriver had shaft dimensions matched to the robotic arm guide and navigation tracker compatibility. Primary outcomes included pedicle screw placement accuracy using Gertzbein-Robbins classification and technical feasibility.

Results

A total of 708 screws were placed in the custom screwdriver group versus 760 in controls. Clinically acceptable screw placement (Gertzbein-Robbins grades A&B) was achieved in 99.15 % (702/708) versus 99.07 % (753/760) respectively (difference: 0.08 %, 95 % CI: 1.14 %–1.30 %, p = 0.880). Non-inferiority was demonstrated with the lower confidence interval (−1.14 %) exceeding the predefined margin (−3 %). Technical feasibility was 100 % with no conversion required. Operative time (142.3 ± 38.5 vs 148.7 ± 40.2 min, p = 0.239), blood loss (537.2 ± 328.0 vs 550.0 ± 359.0 ml, p = 0.793), and per-screw placement time (6.2 ± 1.8 vs 6.4 ± 1.7 min, p = 0.426) were comparable. Implant costs were significantly lower in the custom screwdriver group (USD 559.50 ± 224.35 vs 1973.47 ± 934.80, p < 0.001).

Conclusions

Custom instrument design successfully maintained surgical precision while enabling third-party implant integration within robotic spine surgery workflows. This approach demonstrates enhancement of robotic system modularity without compromising accuracy, safety, or operational efficiency.

Clinical relevance

This innovation enables surgeons to select optimal implants based on clinical evidence rather than proprietary constraints, potentially improving patient outcomes while reducing healthcare costs through enhanced system flexibility.

Level of evidence

III.

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来源期刊

Journal of orthopaedics ORTHOPEDICS-

CiteScore

3.50

自引率

6.70%

发文量

202

审稿时长

56 days

期刊介绍： Journal of Orthopaedics aims to be a leading journal in orthopaedics and contribute towards the improvement of quality of orthopedic health care. The journal publishes original research work and review articles related to different aspects of orthopaedics including Arthroplasty, Arthroscopy, Sports Medicine, Trauma, Spine and Spinal deformities, Pediatric orthopaedics, limb reconstruction procedures, hand surgery, and orthopaedic oncology. It also publishes articles on continuing education, health-related information, case reports and letters to the editor. It is requested to note that the journal has an international readership and all submissions should be aimed at specifying something about the setting in which the work was conducted. Authors must also provide any specific reasons for the research and also provide an elaborate description of the results.