Titanium ball joint total ossicular replacement prosthesis--experimental evaluation and midterm clinical results

During reconstruction of the ossicular chain, there is a need to address the forces and loads caused by the ambient atmospheric pressure variations and the resulting tympanic membrane movements. It is understood that when a rigid middle ear prosthesis is inserted the malleoincudal joint, a keyfactor in controlling pressure variations in the middle ear space is bypassed. In this paper we describe a modified total titanium ossicular replacement prosthesis with an innovative micro ball joint in the headplate which is designed to compensate for tympanic membrane movements caused by atmospheric pressure variations. The characteristics of this modified prosthesis were examined in temporal bone experiments and compared to the standard titanium total ossicular reconstruction prosthesis. Sound-induced stapes footplate movements were investigated by means of a Laser vibrometer and revealed no significant differences between the two prostheses in vitro. Intraoperatively, the insertion of the modified prosthesis required more delicate handling. The angle between the shaft and the headplate was variable and ranged from 60 to 90° as estimated by the surgeon. Twelve consecutive patients were eligible for clinical evaluation. The pure tone average (PTA) air-bone gap after a mean follow up period of 32 months was 18.8 dB. Furthermore, no extrusion, dislocation or other adverse events were observed. We conclude that the modified total ossicular replacement prosthesis with integrated micro ball joint yields similar volume velocities of the stapes footplate in the laboratory experiments compared to the standard rigid prosthesis. The audiological and morphological results are encouraging and show that the mobile prosthesis headplate adjusting to the level of the tympanic membrane is a further step in the development of a physiological middle ear implant. This article is part of a special issue entitled "MEMRO 2012".