Nowadays, numerous internal bone remodelling concepts are under development, in order to estimate long-term functionality of implants by evaluating the intensity of stress-shielding effect. This effect is also analysed for the implants for direct skeletal attachment, considered as a better exoprosthesis fixation method than prosthetic sockets. Most of bone remodelling approaches are based on basic concepts, differing with certain assumptions, which may affect the accuracy of the results. This article compares commonly used internal bone remodelling concepts and evaluates the functionality of the proposed Limb Prosthesis Osseointegrated Fixation System for direct skeletal attachment of limb prosthesis in comparison with two currently available implants: the Intraosseous Transcutaneous Amputation Prosthesis and the Osseointegrated Prostheses for the Rehabilitation of Amputees. Three concepts were chosen: without and with lazy zone and with the use of quadratic formula which considers bone overloading. Therefore, three finite element models were created with identical femur implanted with each of analysed implants. The implants were loaded with loads that refer to two stages of gait cycle (heel strike and toe-off). The analysed concepts have given similar results, allowing to assume that each of them can be successfully used to estimate internal bone remodelling around analysed implants for direct skeletal attachment of limb prosthesis. The results also present higher functionality of the proposed implant for direct skeletal attachment of limb prosthesis due to a significant reduction in stress-shielding in the analysed areas around implant in comparison with the Intraosseous Transcutaneous Amputation Prosthesis and the Osseointegrated Prostheses for the Rehabilitation of Amputees. It suggests that the proposed design is a better alternative to the currently used solutions.
The purpose of the research was to evaluate the influence of selected parameters of the implants for bone anchored prostheses on possibility of conducting static load bearing exercises and stress-shielding intensity. A press-fit implant, a threaded implant, and the proposed design were compared using the finite element method. For the analyses two features were examined: diameter (19.0 – 21.0 mm) and length (75.0 – 130.0 mm). To define the possibility of conducting rehabilitation exercises the micromotion of implants while axial loading with a force up to 1000 N was examined to evaluate the changes at implant-bone interface. The stress-shielding intensity was estimated by bone mass loss over 60 months. The results suggest that, in terms of micromotion generated during rehabilitation exercises, the threaded (max. micromotion of 16.00μm) and the proposed (max. micromotion of 45.43μm) implants ensure low and appropriate micromotion. In the case of the press-fit solution the load values should be selected with care, as there is a risk of losing primary stabilisation. The allowed forces (that do not stimulate the organism to generate fibrous tissue) were approx. 140 N in the case of the length of 75 mm, increasing up to 560 N, while using the length of 130 mm. Moreover, obtained stress-shielding intensities suggest that the proposed implant should provide appropriate secondary stability, similar to the threaded solution, due to the low bone mass loss during long-term use (improving at the same time more bone remodelling in distal Gruen zones, by providing lower bone mass loss by approx. 13% to 20% in dependency of the length and diameter used). On this basis it can be concluded that the proposed design can be an appropriate alternative to commercially used implants.