Introduction of innovations in joint arthroplasty: Recommendations from the 'EFORT implant and patient safety initiative'.

With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 'Introduction of Innovation', combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies.

1st EFORT European Consensus "Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices": Background, Delphi Methodology & Consensus process.

The objectives of the 1st EFORT European Consensus on 'Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices' were foremost to focus on patient safety by establishing performance requirements for medical devices. The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel. Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745.

Metal Artefact Reduction Sequences (MARS) in Magnetic Resonance Imaging (MRI) after Total Hip Arthroplasty (THA) : A non-invasive approach for preoperative differentiation between periprosthetic joint infection (PJI) and aseptic complications?

Background: In the past, radiographic imaging was of minor relevance in the diagnosis of periprosthetic joint infections (PJI). Since metal artefact reduction sequences (MARS) are available, magnetic resonance imaging (MRI) has become a promising diagnostic tool for the evaluation of hip arthroplasty implants. The purpose of the present study was to evaluate the efficacy of MARS-MRI in comparison to established diagnostic tools to distinguish between aseptic failure and PJI.

Vitamin E-blended highly cross-linked polyethylene liners in total hip arthroplasty: a randomized, multicenter trial using virtual CAD-based wear analysis at 5-year follow-up.

Background: Progressive oxidation of highly cross-linked ultra-high molecular weight (UHMPWE-X) liners is considered to be a risk factor for material failure in THA. Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE) were supplemented into the latest generation of polyethylene liners. To prevent inhomogenous vitamin E distribution within the polymer, blending was established as an alternative manufacturing process to diffusion.