Determining the porous structure for optimal soft-tissue ingrowth: An in vivo histological study.

The success of osseointegrated transcutaneous prostheses depends on a soft-tissue seal forming at the skin-implant interface in order to prevent infection. Current designs include a flange with drilled holes or a subdermal barrier with a porous coating in an attempt to promote soft-tissue attachment. However, the soft-tissue seal is not reliably achieved despite these designs and infection remains a significant problem. This study investigated soft-tissue integration into fully porous titanium alloy structures with interconnected pores. The study aimed to determine the effect of altering pore and strut size combinations on soft-tissue ingrowth into porous titanium alloy structures in vivo. It was hypothesized that implants with a more open porous structure with larger pore sizes would increase soft-tissue ingrowth more than less open porous structures. Porous titanium alloy cylinders were inserted into sheep paparaspinal muscles (n = 6) and left in situ for four weeks. A histological assessment of soft-tissue ingrowth was performed. Percentage soft-tissue pore fill, cell nuclei density and blood vessel density were quantified. The results showed that larger pore sizes were supportive of soft-tissue ingrowth. A structure with a pore size of 700μm and a strut size of 300μm supported revascularisation to the greatest degree. A flange with this structure may be used in future studies of osseointegrated transcutaneous prostheses in order to enhance the soft-tissue seal.