Please check your email for the verification action. You may continue to use the site and you are now logged in, but you will not be able to return to the site in future until you confirm your email address.
Introduction. Beneath infection, instability and malalignment, aseptic tibialcomponentloosening remains a major cause of failure in total knee arthroplasty (TKA) [1]. This emphasizes the need for stable primary and long-term secondary fixation of tibial baseplates. To evaluate the primary stability of cemented tibial baseplates, different pre-clinical test methods have been undergone: finite element analysis [2], static push-out [3,4] or dynamic compression-shear loading [5] until interface failure. However, these test conditions do not reflect the long-term endurance under in vivo loading modes, where the tibial baseplate is predominantly subjected to compression and shear forces in a cyclic profile [5,6]. To distinguish between design parameters the aim of our study was to develop suitable pre-clinical test methods to evaluate the endurance of the implant-cement-bone interface fixation for tibial baseplates under severe anterior (method I) and internal-external torsional (method II) shear test conditions. Materials & Methods. To create a clinically relevant cement penetration pattern a 4. th. generation composite bone model was customised with a cancellous core (12.5 PCF cellular rigid PU foam) to enable for high cycle endurance testing. VEGA System. ®. PS & Columbus. ®. CRA/PSA ZrN-multilayer coated tibial baseplates (2×12) were implanted in the customised bone model using Palacos. ®. R HV bone cement (Figure 1). An anterior compression-shear test (method II) was conducted at 2500 N for 10 million cycles and continued at 3000 N & 3500 N for each 1 million cycles (total: 12 million cycles) simulating post-cam engagement at 45° flexion. An internal-external torsional shear test (method II) was executed in an exaggeration of clinically relevant rotations [7,8] with ±17.2° for 1 million cycles at 3000 N tibio-femoral load in extension. After endurance testing either under anterior shear or internal-external torsion each tibial baseplate was mounted into a testing frame and maximum push-out strength was determined [3]. Results. The cement penetration depth and characteristic pattern were comparable to 3D-CT scans of 24 cemented human tibiae from a previous study [5]. From the final push-out testing, no statistical significant differences could be found for anterior compression-shear testing (method I) with VEGA System. ®. PS (2674 ± 754 N) and Columbus. ®. CRA/PSA (2177 ± 429 N) (p = 0.191), as well as internal-external torsional shear testing (method II) between VEGA System. ®. PS (2561 ± 519 N) and Columbus. ®. CRA/PSA (2825 ± 515 N) tibial baseplates (p = 0.399). Discussion. The newly developed methods allow the evaluation of the endurance behaviour of the implant-cement-bone interface fixation for tibial baseplates in comparison to clinically long-term established knee systems, based on a combination of a suitable artificial bone model and severe anterior and internal-external torsional high cycle shear test conditions