Open Tübingen Titanium Prostheses for Ossiculoplasty: A Prospective Clinical Trial

Abstract

Objective 

The overall purpose of the study was the evaluation of the efficacy of Tübingen titanium prostheses (TTPs) for ossiculoplasty.

Study Design 

A two-part clinical study of 216 patients undergoing ossiculoplasty was performed. The first part was a prospective study using TTPs (n = 114). The second part involved study of historical control patients (n = 102) with gold and ceramic prostheses.

Interventions 

All patients underwent ossiculoplasty.

Main Outcome Measures 

Measures included median air conduction thresholds and air-bone gaps.

Results 

All patients were per-protocol patients. When the air-bone gap “gold standard” (i.e., ≤10 dB) was investigated in the main speech spectrum, partial TTPs reached this level at 2 kHz in 44% (n = 22) and at 3 kHz in 38% (n = 19). Gold and ceramics revealed significantly lower values. Similar results were obtained for total prostheses. Differences for TTPs and ceramics were statistically significant (Mann-Whitney U test, α = 5%).

Conclusion 

The use of TTPs for ossiculoplasty is an efficient treatment method.