Swiss national spinal implant registry SIRIS Spine: methods and first results.

Introduction: Spine registries are important for advancing the field to provide evidence for clinical and health policy decision-making. Research question: The objective is to introduce the Swiss Implant Registry "SIRIS Spine" as one of the world's first mandatory nationwide spinal implant registries for selected spinal surgeries. Material and methods: SIRIS Spine is governed by the SIRIS Foundation, Switzerland. EUROSPINE is commissioned to operate the registry. Collected patient data includes demographic, clinical, and implant information and may additionally include electronic patient-reported outcome measures. Inclusion criteria are growing stepwise. Results: Between the years 2021-2023, 12,815 surgeries for 11,789 patients from 91 hospitals were registered. This includes 75,522 implants from 40 manufactures. Reoperations and revisions were registered in 6.9 %. The most frequent pathology was degenerative disease (61.6 %), followed by osteoporotic fractures (12.4 %), and non-degenerative spondylolisthesis (5.4 %). The mean age was 66.8 (standard deviation (SD) 13.7) years. Women (58.7 %) were slightly more frequently included than men. Almost half of the surgeries were preceded by one or several prior surgeries at the same or adjacent segment (49.6 %), after excluding 1'367 patients with missing information. Discussion and conclusion: The SIRIS Spine registry has successfully captured initial data from the involved Swiss hospitals. Involvement of all key stakeholders including specialist societies has proven to be important and a clear success factor. The primary challenge identified was the complexity of inclusion criteria, which has impeded data validation. Future efforts will focus on simplifying criteria, rigorously validating data completeness and accuracy, and leveraging data for quality improvement and comparative analyses.