Development of tracheal prostheses made of porous titanium: a study on sheep.

Authors report the development of a biomaterial to be used for tracheal and laryngeal reconstruction. This experimentation follows the replacement of trachea in rats with porous titanium implants. The aim of the study is to test this type of prosthesis on sheep, whose trachea is of comparable size to that of humans. Six ewes were implanted with porous titanium implants after resection of 5 cm of trachea. The planned period for the implantation was from 3 to 6 months before the sacrifice of the animals for histological analysis. After a simple immediate postoperative course, the implantations developed complications of tracheal patency, responsible for four deaths (tracheal obstruction by mucous plug n = 2, inferior necrosis of trachea n = 1, pneumopathy n = 1). The two remaining sheep presented no complications. The mechanical performance of the prostheses was good. The histological results showed an inflammatory stenosis of the tracheo-prosthetic junctions, which was not the direct result of death. The protheses were integrated by the surrounding tissue, but endoprosthetic colonisation by pseudostratified ciliated columnar epithelium was low or nil. The absence of endoprosthetic lining was responsible for the complications. The biocompatibility of the biomaterial is not in question, but the surgical procedure will have to be modified by an endoprosthetic mucous graft before implantation so as to accelerate healing process.