瑞士国家脊柱植入物注册局 SIRIS 脊柱:方法和初步结果
Thorsten Jentzsch1,2, David Bellut1,3, Ralph T Schär1,4
1Scientific Advisory Board (SSAB) SIRIS Spine, Foundation for quality assurance in implant surgery (SIRIS), Bern, Switzerland.
Brain & spine
|January 26, 2026
概括
瑞士脊柱植入物注册中心 (SIRIS Spine) 成功收集了来自11000多名患者和75000个植入物的数据. 正在解决具有复杂标准的挑战,以改善数据验证和质量改进.
科学领域:
- 脊柱手术研究结果研究结果
- 医疗信息学 医疗信息学
- 医疗器械监控 医疗器械监控 医疗器械监控 医疗器械监控
背景情况:
- 脊柱登记册对于临床实践和卫生政策中基于证据的决策至关重要.
- 强制性全国性注册表对于在脊椎外科手术中全面收集数据至关重要.
研究的目的:
- 引入瑞士脊柱植入物注册系统 (SIRIS Spine),这是一个针对特定脊柱手术的强制性全国性注册系统.
- 详细说明注册表的治理,数据收集方法和最初的范围.
主要方法:
- 塞里斯脊柱注册表收集人口统计,临床和植入物数据,可选的是患者报告的结果.
- 包括标准逐渐扩大.
- 数据由SIRIS基金会管理,由EUROSPINE运营.
主要成果:
- 从2021-2023年,来自91家医院的12815次手术 (11789名患者) 被注册,涉及75,522种植入物.
- 最常见的病理是退行性疾病 (61.6%),其次是骨质疏松性骨折 (12.4%).
- 重复手术/修改占6.9%的病例,其中49.6%的手术涉及同一或相邻部分的先前手术.
结论:
- 瑞士脊柱注册系统SIRIS成功启动了瑞士医院的数据采集.
- 利益相关者的合作对于注册表的成功至关重要.
- 简化纳入标准和加强数据验证是提高质量的未来主要优先事项.
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