ABSTRACT
Following the tradition of the IDES European Hip Registry inaugurated by M. E. Müller in the 1960s, the Institute for Evaluative Research in Orthopaedic Surgery at the University of Bern started a new era of data collection using internet technology (www.memdoc.org). With support of the Swiss Orthopaedic Society, the pilot of the Swiss Orthopaedic Registry was conducted, and in cooperation with different academic and non-academic centers the practicability of integrating the various data collection instruments into the daily clinical workflow was evaluated. Three different sizes of hip and knee questionnaires were compiled, covering the individual demands of the participating hospitals whereby the smaller questionnaires always represent a subset of the next larger one. Different types of data collection instruments are available: the online interface, optical mark reader paper questionnaires, and barcode sheets. Precise implant tracking is implemented by scanning the implant barcodes directly in the operating theaters and linking them to the clinical data set via a central server. In addition, radiographic information can be linked with the clinical data set. The pilot clinics suggested enhancements to the user interface and additional features for data management. Also, recommendations were made to simplify content in some instances and diversify in others. With a new software release and adapted questionnaires the Swiss Orthopaedic Registry was officially launched in Summer 2005.
Subject(s)
Orthopedics , Registries , Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Data Collection/methods , Humans , Internet , Program Development , SwitzerlandABSTRACT
New joint replacement registries are being widely implemented across national and international organizations. The need for a continuous long-term post-market surveillance of implants has been recognized, and has become increasingly important to ensure the quality of prosthetic components. Registry data with large case numbers represent an acceptable alternative to controlled randomized clinical trials, which are often difficult to conduct in orthopedic surgery. The variety of implants and procedures in spinal surgery not only induces the same need for long-term monitoring of post-surgical product performance as in the joint replacement subspecialties, but also renders essential the establishment of a comprehensive spine registry for all major pathologies and interventions. In cooperation with the M.E. Müller Institute for Evaluative Research in Orthopedic Surgery (MEM-CED) at the University of Berne, Switzerland, the Spine Society of Europe (SSE) has launched Spine Tango: the first modular and multilevel European online registry for spinal surgery. Within Spine Tango, the major challenge in registry design and structure is the definition of and agreement upon a core set of questions as a common European dataset. Additional questions for national or individual interest can also be dynamically added to the core dataset. An automated implant tracking system has also been setup, which allows highly precise product documentation without additional work for clinical staff members.