The in-vivo effects of an intramedullary implant evoking a constant radial stress to bone. An animal study in the tibia of the goat

Abstract

Initial stability is essential for successful bone ingrowth into non-cemented prostheses. An entire new concept to increase the initial stability directly after implantation of intramedullary stems was developed (the tension rod prosthesis). The concept is based on a tension rod made out of memory metal that pulls a proximal stem of a prosthesis towards a distal anchor with a constant force. The stress generated along the long axis of the bone produces a radial stress around the prosthesis in the proximal femur. The main goal of this design is to increase the primary stability of the prosthesis during the ingrowth phase and to prevent stress shielding and bone resorption, as realized by the radial force applied to the proximal endosteum of the bone. To assess the efficacy of this concept and to collect data for the anchor design, an implant was developed for implantation into the tibia of the goat. Analyses of push-out strength and bone reactions were performed postoperatively. After 48 weeks the push-out strength of this implant was increased and the histological evaluation showed almost complete osseousintegration. Histomorphometrical analysis showed pronounced, permanent periosteal reactions, located around the anchor of the implant, which generates the radial stress. These first results showed that the bone can withstand the radial stress provoked by the anchor of the tension rod. It is concluded that the concept of a tension rod prosthesis is viable.