The SWISSspine Registry

Cost containment is a pressing issue in all modern health care systems. Although medical innovations, demographic changes, and an ever-increasing entitlement mentality of patients have lead to severe financial problems, convincing and sustainable solutions to overcome this crisis are not at hand. The orthopaedic sector is always in the focus of debate; orthopaedic interventions, especially total joint arthroplasty, are expensive and do not directly save lives. However, their impact on patients’ quality of life and regained mobility and independence are undisputed. In contrast, scientific evidence is lacking for many interventions and innovations of the fastest growing orthopaedic subspecialty, that is, spinal surgery. Accordingly, opinion leaders in spinal surgery recommend cautious approaches toward emerging new techniques and devices and closer scrutiny of spinal implants and their use for unapproved indications. They further suggest randomized controlled trials (RCTs) for new implants and indications and rigorous postmarket surveillance for adverse events (1).

Reimbursement for Total Disc Arthroplasty in Switzerland

Although total disc arthroplasty (TDA) is nowadays reimbursed in many European countries such as Germany and the United Kingdom, the Swiss federal office of health has chosen an approach similar to the previously mentioned expert proposals. Instead of conducting RCTs, it was preferred to conduct an observational study, thereby recognizing the value and practicability of such an endeavor (2). Until March 2005, TDA and balloon kyphoplasty (BKP) belonged to the so-called negative list of medical services. Interventions were not reimbursed and expenses for complications resulting from the treatments were directly charged to the respective patients. With increasing evidence about the success of TDA and BKP resulting from clinical studies and health technology assessment (HTA) projects, it was decided to temporarily reimburse the new technologies under the prerequisite that all implanted discs and used BKP sets are documented in a national registry.

A Capacious Alliance—Industry, Politics, Medicine, Science

Given the new restrictions for market release of medical innovations in Switzerland, the implant industry approached the decision-making political bodies and the Swiss Society for Spinal Surgery (SGS). A consensus was formed to implement a medical device registry for collecting data and providing the evidence of the safety and “efficiency” of the new treatments, that is, their performance in the clinical setting (3). The Institute for Evaluative Research in Orthopaedic Surgery at the University of Bern (IEFO), an international leader in the field of registry implementation (4,5,6), was mandated to serve as technology provider and organizer of the SWISSspine registry. In a working group consisting of stakeholders of industry, the SGS, and the IEFO, the different tasks and duties were assigned. An expert committee of the society worked up the medical content, the industry partners provided funding according to market share and support for device-related questions, and the IEFO implemented all questionnaires in an online and paper-based version for optical mark reader (OMR) scanning on its scientific documentation portal www.memdoc.org (Figs. 31.1, 31.2, and 31.3). Hereby, all content needed to be available in three of the four official Swiss languages: German, French, and Italian.

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