Experimental assessment of a new direct fixation implant for artificial limbs.

An alternative to prosthetic socket rehabilitation of patients with transfemoral amputation is realized by means of direct skeletal fixation devices. offering significant improvements in mobility and comfort. However, strain shielding due to high stiffness of these metal-based implants causes considerable and progressive bone loss. To overcome this phenomenon a new concept of a direct fixation implant, in form of a collared metallic pin articulating inside a polymer intramedullary part, was developed. In this study we used experimental and finite element techniques to assess whether the novel concept produced a more physiological strain distribution in the bone as compared to a standard titanium implant. Cortical strains were measured experimentally on seven human cadaver femora, both intact and implanted with a generic standard implant and the new implant. Three load configurations were considered, simulating: heel strike, toe off and one leg stance. A finite element model derived from computed tomography data was used to calculate strains in intact bone and bone with generic models of the two implant types. Significant strain shielding occurred around both implant types, albeit that for the novel design strain shielding was generally less (p<0.04). Significant differences in strain shielding between both implant types were obtained for heel strike at the distal (p<0.04) and the middle level (p<0.03), as well as for the one leg stance at the middle level (p<0.03) showing 21-29% less strain shielding for the new implant in these cases. Finite element results were in agreement with the experimental findings: more strain shielding for the standard implant as compared to the novel design. In fact, the benefit of the new design was bigger in the simulations as compared to the experimental measurements, which was attributed to the idealized collar-cortex fit in the FE model of the new design which was not obtained in the experiments. In conclusion, the study showed that the new implant has a potential to increase distal load transfer to the femur and reduce strain shielding as compared with the standard implant. Collar-cortex contact is an important aspect and requires further attention when developing the surgical technique. The encouraging results obtained in this study justify further development of this concept in order to improve the quality and applicability of direct skeletal fixation devices for patients requiring a transfemoral amputation.

Simulated bone remodeling around two types of osseointegrated implants for direct fixation of upper-leg prostheses.

Direct attachment of an upper leg prosthesis to the skeletal system by a percutaneous implant is an alternative solution to the traditional socket fixation. In this study, we investigated long-term periprosthetic bone changes around two types of fixation implants using two different initial conditions, namely immediate post-amputation implantation and the conventional implantation after considerable time of socket prosthesis use. We questioned the difference in bone modeling response the implants provoked and if it could lead to premature bone fracture. Generic CT-based finite element models of an intact femoral bone and amputated bone implanted with models of two existing direct-fixation implants, the OPRA system (Integrum AB) and the ISP Endo/Exo prosthesis (ESKA Implants AG) were created for this study. Adaptive bone-remodeling simulations used the heel-strike and toe-off loads from a normal walking cycle. The bone loss caused by prolonged use of socket prosthesis had more severe effects on the ultimate bone quality than adaptation induced by the direct-fixation implants. Both implants showed considerable bone remodeling; the titanium screw implant (OPRA system) provoked more bone loss than the porous coated CoCrMo stem (ISP implant). The chance of the peri-prosthetic bone fracture remained higher for the post-socket case as compared to the direct amputation cases. In conclusion, both direct-fixation implants lead to considerable bone loss and bone loss is more severe after a prolonged period of post-socket use. Hence, from a biomechanical perspective it is better to limit the post-socket time and to re-design direct fixation devices to reduce bone loss and the probability of peri-prosthetic bone fractures.

Numerical analysis of an osseointegrated prosthesis fixation with reduced bone failure risk and periprosthetic bone loss.

Currently available implants for direct attachment of prosthesis to the skeletal system after transfemoral amputation (OPRA system, Integrum AB, Sweden and ISP Endo/Exo prosthesis, ESKA Implants AG, Germany) show many advantages over the conventional socket fixation. However, restraining biomechanical issues such as considerable bone loss around the stem and peri-prosthetic bone fractures are present. To overcome these limiting issues a new concept of the direct intramedullary fixation was developed. We hypothesize that the new design will reduce the peri-prosthetic bone failure risk and adverse bone remodeling by restoring the natural load transfer in the femur. Generic CT-based finite element models of an intact femur and amputated bones implanted with 3 analyzed implants were created and loaded with a normal walking and a forward fall load. The strain adaptive bone remodeling theory was used to predict long-term bone changes around the implants and the periprosthetic bone failure risk was evaluated by the von Mises stress criterion. The results show that the new design provides close to physiological distribution of stresses in the bone and lower bone failure risk for the normal walking as compared to the OPRA and the ISP implants. The bone remodeling simulations did not reveal any overall bone loss around the new design, as opposed to the OPRA and the ISP implants, which induce considerable bone loss in the distal end of the femur. This positive outcome shows that the presented concept has a potential to considerably improve safety of the rehabilitation with the direct fixation implants.

A comparative finite-element analysis of bone failure and load transfer of osseointegrated prostheses fixations.

An alternative solution to conventional stump-socket prosthetic limb attachment is offered by direct skeletal fixation. This study aimed to assess two percutaneous trans-femoral implants, the OPRA system (Integrum AB, Göteborg, Sweden), and the ISP Endo/Exo prosthesis (ESKA Implants AG, Lübeck, Germany) on bone failure and stem-bone interface mechanics both early post-operative (before bony ingrowth) and after full bone ingrowth. Moreover, mechanical consequences of implantation of those implants in terms of changed loading pattern within the bone and potential consequences on long-term bone remodeling were studied using finite-element models that represent the intact femur and implants fitted in amputated femora. Two experimentally measured loads from the normal walking cycle were applied. The analyses revealed that implantation of percutaneous prostheses had considerable effects on stress and strain energy density levels in bone. This was not only caused by the implant itself, but also by changed loading conditions in the amputated leg. The ISP design promoted slightly more physiological strain energy distribution (favoring long-term bone maintenance), but the OPRA design generated lower bone stresses (reducing bone fracture risk). The safety factor against mechanical failure of the two percutaneous designs was relatively low, which could be improved by design optimization of the implants.