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Open Tübingen titanium prostheses for ossiculoplasty: a prospective clinical trial
H P Zenner1, A Stegmaier, R Lehner
1Department of Otolaryngology, University of Tübingen, Tübingen, Germany.
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., < or =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, alpha = 5%).
Conclusion:
The use of TTPs for ossiculoplasty is an efficient treatment method.
