Knee arthroplasty with a rotating hinge knee (RHK) prosthesis has become an important clinical treatment option for knee revisions and primary patients with severe varus or valgus deformities and instable ligaments. The rotational axle constraints the anterior-posterior shear and varus-valgus moments, but currently used polyethylene bushings may fail in the mid-term due to insufficient creep and wear resistance of the material. Due to that carbon-fibre-reinforced (CFR) PEEK as an alternativ bushing material with enhanced creep, wear and fatigue behaviour has been introduced in a RHK design [Grupp 2011, Giurea 2014]. The objective of our study was to compare results from the pre-clinical biotribological characterisation to ex vivo findings on a series of retrieved implants. In vitro wear simulation according to ISO 14243-1 was performed on rotating hinge knee devices (EnduRo® Aesculap, Germany) made out of cobalt-chromium and of a ZrN multi-layer ceramic coating for 5 million cycles. The mobile gliding surfaces were made out of polyethylene (GUR 1020, β-irradiated 30 ± 2 kGy). For the bushings of the rotational and flexion axles and the flanges a new bearing material based on CFR-PEEK with 30% PAN fiber content was used. Analysis of 12 retrieved EnduRo. ®. RHK systems in cobalt-chromium and ZrN multi-layer in regard to. -. loosening torques in comparison with initial fastening torques. -. Optical, DSLR camera and stereo light microscope analysis. -. distinction between different wear modes and classification with a modified HOOD-score. -. SEM & EDX of representative samples. -. surface roughness and depth profilometry. with a focus on the four CFR-PEEK components integrated in the EnduRo. ®. RHK design. For the rotating hinge
Introduction. Today TKR is considered one of the most successful operative procedures in orthopedic surgery. Nevertheless, failure rates of 2 – 10% depending on the length of the study and the design are still reported. This provides evidence for further development in knee arthroplasty. Particularly the oxide ceramics used now in THA show major advantages due to their excellent tribological properties, their significantly reduced third-body wear as well as their high corrosion resistance. A further advantage of ceramic materials is their potential use in patients with metal allergy. Metallic wear induces immunological reactions resulting in hypersensitivity, pain, osteolysis and implant loosening. The purpose of our study was to examine the safety of the tibial component of a novel all-ceramic TKR. Materials and Methods. We tested the tibial components of the primary knee implant BPK-S Integration Ceramic. Both the tibial and the femoral component consist of BIOLOX®delta ceramic The standards ISO 14879-1 and ASTM F1800-07 describe the test set-up for the experimental fatigue strength testing of tibial components from knee implants. We conducted the testing with a significantly increased maximum load of 5,300 N (900 N are required). A final burst strength test was carried out after the fatigue load testing in the same embedding and with the same test set-up. Results. No specimen failed during fatigue load testing. The subsequent post-fatigue burst strength testing showed a maximum strength against fracture of at least 9.7 kN for size 3 and at least 12.1 kN for size 6. Discussion. The good results of the strength testing of the tibial component of the BPK-S Integration Ceramic tibial plateau supported the good initial clinical outcome without any implant specific complications of this
The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. Registry data show good clinical outcome; however, concerns over the cement-tibial interface have been reported. We used retrieval analysis to give further insight into this controversial topic. We examined 12 titanium (Ti) PFC Sigma implants, eight cobalt-chromium (CoCr) PFC Sigma implants, eight cobalt-chromium PFC Sigma rotating platform (RP) implants, and 11 Attune implants. We used a peer-reviewed digital imaging method to quantify the amount of cement attached to the backside of each tibial tray. We then measured: 1) the size of tibial tray thickness, tray projections, peripheral lips, and undercuts; and 2) surface roughness (Ra) on the backside and keel of the trays. Statistical analyses were performed to investigate differences between the two designs.Objectives
Methods