Ossiculoplasty with polymaleinate ionomeric prosthesis

Abstract

With the continued concern over the possible transmission of viral infections through homologous middle ear implants, there is increasing pressure to develop a truly biocompatible alloplastic middle ear prosthesis. The polymaleinate ionomer, which has been used in dentistry as a filling and luting material for more than 15 years, has recently been used to construct total and partial ossicular replacement prostheses. In an attempt to evaluate these new implants, a multicenter prospective clinical trial was initiated. To date, 92 patients have undergone implantation. The follow-up interval ranged from 3 months to 22 months. Although it is premature to discuss the long-term results, the preliminary surgical experience and audiometric data with these implants are reviewed. From a surgical perspective, the ionomeric prostheses were easily contoured with a diamond burr and were not prone to shattering. Preliminary follow-up audiometric data were available on 80 patients (59 partial ossicular replacement prostheses and 21 total ossicular replacement prostheses). Of the 59 partial ossicular replacement prostheses the air-bone gaps (average of 500 Hz, 1 kHz, 2 kHz and 3 kHz) were as follows: 0 dB to 10 dB, 15 (25%) of 59; 11 dB to 20 dB, 20 (34%) of 59; 21 dB to 30 dB, 11 (19%) of 59; and greater than 30 dB, 13 (22%) of 59. Of the 21 total ossicular replacement prostheses the air-bone gaps were as follows: 0 dB to 10 dB, 6 (29%) of 21; 11 dB to 20 dB, 6 (29%) of 21; 21 dB to 30 dB, 5 (24%) of 21; and greater than 30 dB, 4 (19%) of 21.

Titanium and Glass-Ionomer Cement as Ossicular Replacement Materials: Biocompatibility Results after Implantation in the Rabbit

“…Because of this, in vitro experiments cannot be substituted for carefully controlled long-range animal studies [5]. Although there are only a few reports of titanium for bone replacement in the middle ear [10,25], and a greater number of clinical applications of glass-ionomer cement [7][8][9], the clinical results correlate with the results of our animal study.…”

“…Glass-ionomer cement was first developed as a material in the field of dentistry, exhibiting good functional and biological results [6]. The use of glass-ionomer cement for middle ear prostheses is now widespread [7][8][9], but titanium is just now beginning to be used in human middle ear surgery [10].…”

Titanium as a biomaterial for ossicular replacement: results after implantation in the middle ear of the rabbit

“…In addition, carbon implants may be metabolized by certain microorganisms [4]. More recently, ionomeric cement was introduced in middle ear surgery [3,12,28,29]. In animal studies, biodegradation could not be assessed after 336 days of implantation [11].…”

Ergebnisse der Tympanoplastik Typ III mit autogenem Amboss sowie Ionomerzement- und Titanimplantaten

“…Die gute Mittelohrkompatibilität des Werkstoffs ließ sich auch bei den jetzigen Untersuchungen bestätigen [6,7,28]. Selbst bei sich langsam nach medial verlagernder Paukenabdeckung wurde das Implantat in 15 beobachteten Fällen nicht abgestoßen, sondern die Paukenabdeckung stülpte sich wie ein Handschuhfinger darüber.…”