Pre-clinical characterization of a novel flexible surface stem design for total knee replacements.

Primary stability is crucial for implant osseointegration and the long-term stability of cementless total joint replacements. Biomechanical studies have shown the potential of femoral stems for total knee replacements to reduce micromotions at the bone-implant interface. However, approaches such as focusing on the structural elasticity of the femoral stems are rarely described. Three groups with different femoral stem designs were investigated: group 1: flexible surface stem, group 2: flexible surface stem with open-porous structured lamellas, and group 3: solid stem (reference). The stems were implanted into bone substitute material and dynamically loaded for 1000 cycles. Relative movement and subsidence were measured optically, and axial pull-out forces were determined after dynamic testing. Relative movements increased to 0.10 mm (groups 1 and 2) compared to 0.03 mm (group 3). Subsidence increased to 0.08 mm (group 1) and 0.11 mm (group 2) compared to 0.06 mm (group 3). For each group, subsidence mainly occurred during the first 500 cycles. A similar convergence was observed in the further course. Pull-out forces increased to 1815.0 N (group 1) and 1347.1 N (group 2) compared to 1306.4 N (group 3). The flexible surface stem design resulted in higher relative movements and subsidence, but also exhibited increased pull-out forces. The relative movements were below the critical limit of 0.15 mm and represent a superposition of the elastic deformations of the interacting implant components as well as the micromotion at the bone-implant interface. Therefore, the novel flexible surface stem design appears to offer promising primary implant fixation.