Background: Several types of highly-crosslinked polyethylene with different manufacturing processes and mechanical properties are commercially available, including HIGHCROSS (Medacta). The aim of this registry study is to ascertain the long-term safety of the HIGHCROSS liners in total hip arthroplasty and compare the revision rates with its contemporaries using real-world data to establish their safety and generalizability when used by multiple surgeons.
Methods: The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the Swiss National Joint Registry (SIRIS) were selected for the large number of users of Medacta implants and the availability of long-term results.
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.
View Article and Find Full Text PDFBackground: What is the right surface for an implant to achieve biological fixation? Surface technologies can play important roles in encouraging interactions between the implant surface and the host bone to achieve osseointegration. Preclinical animal models provide important insight into in vivo performance related to bone ongrowth and implant fixation.
Methods: A large animal model was used to compare the in vivo response of HA and plasma-sprayed titanium coatings in a well-reported adult ovine model to evaluate bone ongrowth in terms of mechanical properties in cortical sites, and histology and histomorphometry in cortical and cancellous sites at 4 and 12 weeks.
Knee Surg Sports Traumatol Arthrosc
May 2019
Purpose: It was hypothesized that surgeon's experience as well as bone density play a significant role in achieving accurate cuts with patient-specific instrumentation (PSI). The aim of this study was to compare the accuracy of the tibial cuts in different bone densities made by a highly experienced orthopedic surgeon on one hand and a less experienced orthopedic surgeon on the other.
Methods: Tibial models from three different sawbone densities were developed for this study.