Ionomeric cement implants in the middle ear of the baboon (Papio ursinus) as a primate model.

Faced with an inadequate supply of autogenous materials, the otologic surgeon may have to utilize various alloplastic materials to reconstruct bony middle ear structures. Allogenic materials have fallen into disfavor clinically because of the possible spread of infections. Implantation of the hybrid bone substitute ionomeric cement in viscous or hardened physical states into the middle ears of a primate animal model was undertaken in order to be able to approximate as closely as possible conditions found clinically. The posterior meatal wall was replaced by freshly mixed ionomeric cement in nine baboons (Papio ursinus). After repositioning the meatal flap, the residual skin defect was left to secondary epithelialization. After removal of the stapes superstructure, incus and malleus head, a columella of hardened ionomeric cement was trimmed to the appropriate size and inserted between the footplate and the malleus handle. In three cases the prosthesis shaft was fixed in position with freshly mixed cement near the footplate. The time of follow-up ranged from 47 to 277 days. Gross sections were obtained without decalcification (using a Zeiss saw microtome) and stained with Giemsa solution. In no instance was there any spontaneous epithelialization of the external meatus, although occasional granulation was seen to develop at the free edge of the flap and subepithelially. Epithelialization of the alloplastic columellae occurred as early as 42 days post-implantation. Over the middle ears reconstructed with the viscous cement, there was growth of a thickened epithelium that partially tended to granulate. On light microscopy, the bony footplate area was found to be unaffected by the cement that had been applied when still fluid. Our findings indicate that reconstruction of the posterior meatal wall with the viscous ionomeric cement can be useful clinically. The material does not become dislocated but, as with all other alloplastic materials, spontaneous overgrowth of the adjacent meatal skin is unlikely to occur. The early epithelialization of the columellae and their middle ear compatibility and biostability give support to the excellent tolerability of the ionomeric cement. At present, complications occurring during otoneurological application of the material necessitated its commercial withdrawal from the market in May 1995.