The Swiss National Implant Registry SIRIS: An overview
For all Swiss hospitals that perform total hip arthroplasty (THA) and total knee arthroplasty (TKA), registry of patient- and implant-related data in the Swiss National Implant Registry SIRIS is compulsory due to their participation in the ANQ’s national quality agreement. SIRIS therefore acts as quality control registry for both hospitals and orthopedic implant manufacturers. In the future, spinal implants will also be included more intensively in the registry. In 2021, this came out to about 50,000 surgical interventions on the hip, knee, and spine. The long-term, systematic evaluation of the operations and their outcomes aims to improve the quality of care with the help of real-world evidence.
RAYLYTIC is proud to support these efforts. We’ve made it our goal to sustainably contribute to the transparency, quality assurance, and scientific advancement of orthopedics. Our deep expertise in the automated management and collection of healthcare data has made it possible to support Swiss hospitals in adapting to the growing administrative workloads associated with transferring data to SIRIS.
Automated clinical data management & ePROM transfer helps Swiss hospitals easily fulfill regulatory requirements
For years, the largest names in orthopedic implants – Johnson & Johnson, Aesculap, Mathys, and Zimmer Biomet – have relied on RAYLYTIC to provide highly accurate and independent analysis of implant performance for clinical trials, sponsor-initiated patient registries, and post-market surveillance (PMS) and post-market clinical follow-up (PMCF). Now, the Kantonsspital Winterthur (KSW), one of the ten largest hospitals in Switzerland, is using RAYLYTIC’s UNITY platform as an integrated ePRO collection tool, which automates the collection of PROM instruments as part of clinical routine and their transfer to the registry.
And this transition to completely automated data export represents a welcome change from the time-consuming manual collection of PROMs and case report forms (CRFs) necessary for SIRIS. Up until now, these questionnaires had to be sent via mail or manually entered on the SIRIS website. After all the time and effort needed to collect these data, they were ultimately lost: The KSW wasn’t able to access them for their own internal benchmarking and quality assurance.
The hospital isn’t the only one to benefit from the automated solution either. It is also advantageous for SIRIS since the electronic capture of PROMs and CRFs ensures that they are complete and consistent as well as contain fewer erroneous data.
Fig. 1: The absolute number of TKA performed in Switzerland since the introduction of SIRIS in 2012. In 2021, 98.6% of TKAs were successfully registered in SIRIS.1
Combining implant and treatment data
At RAYLYTIC, we have an established history as a software provider and imaging core lab for the automation of healthcare processes and data collection and analysis for clinical trials. Imaging data management and image analysis are key components of our UNITY platform, which also contains modules for clinical trial design as well as collection eCRFs, ePROs, PROMs and PREMs.
We support medical device manufacturers and hospitals with the automation of routine processes as well as with artificial intelligence in orthopedics and X-ray analysis. Our technology makes the objective and highly precise analysis of radiographic parameters such as fusion, subsidence, migration, and wear, for the evaluation of implant performance. At the same time, relevant patient and follow-up information is obtained through physician questionnaires (CRFs), while patients provide information on their individual perceptions of treatment outcome and quality of life through standardized questionnaires (PROMs).
Fig. 2: The absolute number of THA performed in Switzerland since the introduction of SIRIS in 2012. In 2021, 97.4% of THAs were successfully registered in SIRIS.1
The shared goal of high-quality and complete data
It is obvious that both SIRIS and RAYLYTIC are doing their utmost to make data collection and evaluation for prostheses as simple and efficient as possible. After all, registries can only fulfill their function if the input quality and the acquisition rate are high. Thus, ensuring data quality and completeness is key to achieving the common endeavor: evidence-based and personalized patient care.
By capturing implant-related data in UNITY and transferring it directly to the SIRIS database, we are getting a lot closer to this goal.
1. Swiss National Hip & Knee Joint Registry. Report 2022. Annual Report of the SIRIS Registry Hip & Knee, 2012 – 2021 Ten Years of Swiss Hip and Knee Registry