Implant loosening remains a common cause of total ankle replacement (TAR) revision, and has been associated with wear-mediated osteolysis. Limited pre-clinical studies for TARs have been reported and the variety of experiment settings make it difficult to compare wear rates. Factors such as simulator control mechanism; whether pneumatic or electromechanical, may influence the integrity of the simulator outputs with respect to input profiles. This study compares the wear of a TAR, tested in electromechanical and pneumatic experimental simulators under identical input conditions. Twelve medium BOX® (MatOrtho Ltd) TARs (n=6 for each simulator) were tested in an electromechanical and pneumatic knee simulator (Simulation Solutions, UK) for 3 million cycles (Mc). Standard ‘Leeds’ displacement-controlled inputs were used. Kinematic performance was investigated by comparing the output profiles against the maximum demanded input values. The lubricant used was 25% new-born calf serum and wear was determined gravimetrically.Abstract
Objectives
Methods
Total ankle arthroplasty (TAA) is an alternative to ankle arthrodesis, replacing the degenerated joint with a mechanical motion-preserving alternative. Implant loosening remains a primary cause of TAA revision, and has been associated with wear-mediated osteolysis. Differing implant designs have a major influence on the wear performance of joint replacements. Providing a range of implant sizes allows surgeons a greater intra-operative choice for varying patient anatomy and potential to minimise wear. Minimal pre-clinical testing exists in the literature that investigates the effect of implant size on the wear behaviour. The aim of this study therefore was to investigate the effect of two different implant sizes on the wear performance of a TAA. Six ‘medium’ and six ‘extra small’ BOX® (MatOrtho Ltd, UK) TAA implants, of the same conceptual design and polyethylene insert thickness, were tested in a modified 6 station pneumatic knee simulator. 5 million cycles (Mc) of wear simulation were completed for each implant size, under kinematics aiming to replicate an ankle gait cycle (Figure 1) [1]. The simulator used had six degrees of freedom, of which four were controlled. The maximum axial load was 3150N, equivalent to 4.5 times body weight of a 70kg individual. The flexion profile ranged from −15° plantarflexion to 15° dorsiflexion. Rotation about the tibial component ranged from −2.3° of internal rotation to 8° external rotation, and anterior/posterior (AP) displacement ranged from 3.1 mm anterior to −0.9 mm posterior displacement. The lubricant used was 25% bovine serum supplemented with 0.04% sodium azide to prevent bacterial degradation. The wear of the TAA polyethylene inserts were determined gravimetrically after each Mc, with unloaded soak controls used to compensate for the uptake of moisture by the polyethylene.Background
Materials & Methods
Total ankle replacement (TAR) is a substitute to ankle fusion, replacing the degenerated joint with a mechanical motion-conserving alternative. Compared with hip and knee replacements, TARs remain to be implanted in much smaller numbers, due to the surgical complexity and low mid-to-long term survival rates. TAR manufacturers have recently explored the use of varying implant sizes to improve TAR performance. This would allow surgeons a wider scope for implanting devices for varying patient demographics. Minimal pre-clinical testing has been demonstrated to date, while existing wear simulation standards lack definition. Clinical failure of TARs and limited research into wear testing defined a need for further investigation into the wear performance of TARs to understand the effects of the kinematics on varying implant sizes. Six medium and six extra small BOX® (MatOrtho) TARs will be tested in a modified knee simulator for 5 million cycles (Mc). The combinations of simulator inputs that mimic natural gait conditions were extracted from ankle kinematic profiles defined in previous literature. The peak axial load will be 3.15 kN, which is equivalent to 4.5 times body weight of a 70kg individual. The flexion profile ranges from 15° plantarflexion to 15° dorsiflexion. Rotation about the tibial component will range from −2.3° of internal rotation to 8° external rotation, while the anterior/posterior displacement will be 7mm anterior to −2mm posterior throughout the gait cycle. The components will be rotated through the simulation stations every Mc to account for inter-station variability. Gravimetric measurements of polyethylene wear will be taken at every Mc stage. A contact profilometer will also be used to measure average surface roughness of each articulating surface pre-and-post simulation. The development of such methods will be crucial in the ongoing improvement of TARs, and in enhancing clinical functionality, through understanding the envelope of TAR performance.
