Open Tübingen titanium prostheses for ossiculoplasty: a prospective clinical trial.
OBJECTIVE
The overall purpose of the study was the evaluation of the efficacy of Tübingen titanium prostheses (TTPs) for ossiculoplasty.


METHODS
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.


METHODS
All patients underwent ossiculoplasty.


METHODS
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%).


CONCLUSIONS
The use of TTPs for ossiculoplasty is an efficient treatment method.
Zenner
H P
HP
Department of Otolaryngology, University of Tübingen, Tübingen, Germany.
Stegmaier
A
A
Lehner
R
R
Baumann
I
I
Zimmermann
R
R
D000161:Acoustic Stimulation / Q000295:instrumentation; D000162:Acoustics; D000293:Adolescent; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D009998:Ossicular Prosthesis; D011446:Prospective Studies; D014025:Titanium; D014433:Tympanoplasty
D014025:Titanium