New method of fixation of in-bone implanted prosthesis

Abstract

This article presents results on the effectiveness of a new version of the titanium porous composite skin and bone integrated pylon (SBIP). The SBIP is designed for direct skeletal attachment of limb prostheses and was evaluated in a pre-clinical study with three rabbits. In accordance with the study protocol, a new version of the pylon (SBIP-3) was implanted into the hind leg residuum of three rabbits. The SBIP-3 has side fins that are designed to improve the bond between the bone and pylon. The fins are positioned inside two slots precut in the bone walls; their length can be adjusted to match the thickness of the bone walls. After 13 (animal 1) or 26 wk (animals 2 and 3), the animals were sacrificed and samples collected for histopathological analysis. The space between the fins and the bone into which they were fit was filled with fibro-vascular tissue and woven bone. No substantial inflammation was found. We suggest that if further studies substantiate the present results, the proposed method can become an alternative to the established technique of implanting prostheses into the medullar canal of the hosting bone.

Application of the skin and bone integrated pylon with titanium oxide nanotubes and seeded with dermal fibroblasts

“…6 ). The cross section of the pylon clearly demonstrated the ingrowth of the soft tissues into the pores of the titanium, that was similar in nature to our previous experiments with non modified pylons [22, 45, 46]. With the non modified pylons (control), following 6 months after surgery we observed the patchy fibrovascular ingrowth ( Fig.…”

“…Specification for all modifications of the SBIP pylons, defining the four critical parameters of particle size, pore size, porosity and volume fraction, is uniquely selected and protected by US Patent # 8257435. Durability, resistance to fatigue, safety and efficiency of the SBIP specification has been confirmed in mechanical and animal studies [19, 21, 22, 27, 35 41]. …”

“…In all animals we performed above knee amputation described elsewhere [22]. The anterior and posterior skin flaps at the level of bony resection were marked 4 cm above the knee with a marking pen.…”

Design features of implants for direct skeletal attachment of limb prostheses

“…Similar to SBIP‐2, the SBIP‐3 is also a composite, but includes side elements (fins) that are placed in the precut slots in the cortical bone walls …”

Evaluation of the temporary effect of physical vapor deposition silver coating on resistance to infection in transdermal skin and bone integrated pylon with deep porosity

“…Direct skeletal attachment (DSA) of limb prostheses represents an alternative technology to traditional suspension of prostheses via various socket systems, with clear indications when the sockets cannot be properly fitted. Several preclinical and clinical studies demonstrated biomechanical efficiency of the DSA in rehabilitating patients . However, the rate of implant‐related infections is still high .…”