Swiss National Implant Registry, Spine (SIRIS Spine)

Logical structure of the registry 

The SIRIS Spine registry platform was specifically developed to collect and analyse data related to treatments involving medical devices. The platform was configured to meet specific requirements and shares an implant database with  Spine Tango from EUROSPINE. SIRIS Spine and Spine Tango will utilise the same basic data set. Although the two registries are operated independently of each other, close cooperation between them offers the following major advantages:

• Common, proven registry platform and database for implants
• Enhancements to functionalities will be available simultaneously for both registries
• Statistically robust information can be rapidly obtained through data pooling
• Existing document templates (study protocol template, user documentation etc.)
• wiss Spine Tango clinics avoid having to enter data twice

Users of the SIRIS Spine input mask can be divided into two groups:
Group A: users who will only enter SIRIS Spine data.
Group B: users who will input SIRIS Spine data and the remaining Spine Tango data, as well as any other forms (such as COMI, Oswestry, NDI, medical follow-up and conservative treatment). Both user groups will have only one data entry site in Switzerland – the input web page of the SIRIS Spine implant registry > LINK siris-spine.ch. Access is only granted to registered and authorised users.

Data validation  SIRIS Spine conducts plausibility checks and warns users if entries are deemed “implausible”. EUROSPINE co-operates with the SIRIS Spine Scientific Advisory Board to continuously review the required validation rules for SIRIS Spine data input. 

Data separation  Thanks to a unique key generated by the registry (together with a patient-linking algorithm), reoperations and revisions can be assigned to the primary operation (patients can switch where and by whom they have been treated between operations). Similar to SIRIS Hip & Knee, SIRIS Spine employs an identifier common across all hospitals (based on patient name, date of birth, sex and place of birth).

SIRIS Spine verifications and plausibility checks require the encrypted CHOP codes of the participating clinics. Linking these to the entries inputted into the registry enables the registration rate to be calculated.

Procedures requiring registration

As of January 2021
Primary instrumented spondylodesis on 1-2 segments lumbar or lumbosacral (L1/2 - L5/S1) for degenerative disease or isthmic spondylolisthesis with posterior or postero-lateral access including
-  Posterior interbody fusion (PLIF)
-  Transforaminal interbody fusion (TLIF)
-  Posterior fusion (posterior fusion material)
-  Postero-lateral fusion (fusion material postero-lateral)
(Does not include, for example, procedures caudal to S1, ALIF, XLIF, traumatic or neoplastic pathologies).
 
Reoperation or revision of a lumbar instrumented spondylodesis
All reoperations and revisions for a condition on the same segment or in the connecting segment of a lumbar or lumbosacral spondylodesis originally performed with a posterior or postero-lateral approach on 1-2 segments
-  regardless of the number of segments treated during reoperation or revision (Th1 - Coccyx, Ilium)
-  regardless of the type of surgery (e.g. decompression and/or spondylodesis)
-  regardless of the approach (for example, anterior and/or posterior)
-  regardless of the time point of primary spondylodesis.
(Does not include, for example, reoperations/revisions without a previous lumbar or lumbosacral spondylodesis)

From February 2022
Percutaneous vertebroplasty (with cement without implants) and percutaneous kyphoplasty (with cement plus a device [for example, balloon and/or implant] to restore vertebral height) for the treatment of one or more (suspected) osteoporotic vertebral fractures.
 
Reoperation or revision of vertebroplasty or kyphoplasty
All reoperations and revisions for a disease on the same segment or in the connecting segment of a vertebroplasty or kyphoplasty
-  regardless of the number of segments treated (Th1 -S1)
-  regardless of the type of surgery
-  regardless of the approach
-  regardless of the time point of primary vertebroplasty/kyphoplasty

Enhancement stages The professional medical associations, the ANQ and the SIRIS Foundation are planning the following enhancement stages to SIRIS Spine.

• PROMS (COMI and EQ5D) (Pilot phase 2023) 
• Cervical anterior fusions (2024)

Catalogue of questions for primary operations 

• Patient data (first name, last name, date of birth, sex, patient ID)
• Clinic, surgeon, date of operation
• Primary pathology (degenerative disease, re-operation)
• Diagnostic outliers
• Risk factors (ASA, smoking status, body mass index)
• Type(s) of procedure
• Implant data 
• Complications

Catalogue of questions for revision operations

• Pathology (reason for revision/diagnosis)
• Revision procedure
• Remaining entries as per the primary questionnaire

The SIRIS Spine Scientific Advisory Board continuously reviews whether the questions are up-to-date and, if necessary, further develops them in cooperation with EUROSPINE.

Collection of the implant data

SIRIS Spine will access the same implant database as Spine Tango. This database is continuously maintained and expanded, including those products used exclusively in Switzerland. If a product is missing in the database, a request can be made (a function is available) to add this product and its specifications. Such requests are then forwarded directly to the manufacturing companies.

Collection methods for clinics

SIRIS Spine is a web application. As such, it requires only a connection to the Internet and a web browser (Chrome or Firefox are supported and recommended). It is not possible to make entries via printed forms. A direct data import (web service) function is available.

Support is available for any questions raised by clinics. Training is provided by means of video tutorials, in-person training, manuals and telephone support.

Reporting modalities of SIRIS Spine 

Reports from SIRIS Spine will be made available as soon as sufficient data is available; generally this is expected after three years. For now, the following reporting modalities are planned:

Quarterly report for clinics  The quarterly reports are made available to clinics in a standardised form (including benchmarking). The content of this report is continuously adapted to the requirements of hospitals. The reports include the following information:

• Number of registered procedures (own hospital versus all other hospitals)
• Hospital and implant based revision rates including the revision indication
• Risk factors for revision operations
• Rate of epi- and subfusional spinal re-operations
• Complications related to implants and implant failure rates

Annual report  A comprehensive annual SIRIS Spine report will be drawn up and published. The Evaluation Guideline provides a detailed description of the contents and the statistical analyses employed. The aim of reporting is to achieve transparent publication of information at the level of individual clinics. A specific publication guideline has been drawn up to achieve this.