Page 113 - ENT IMPLANTS CATALOGUE IMPLANTS ORL

Published: Eur Arch Otorhinolaryngol (2006) 263: 347-354. Open Tuebingen Titanium Prostheses for Ossiculoplasty:
DOI: 10.1007/s00405-005-1002-6 A Prospective Clinical Trial
The purpose was to study the hearing results in patients receiving a Kurz Zenner H. P., Stegmaier A., Lehner R., Baumann I.,
titanium Bell partial ossicular replacement prosthesis (PORP) or an Aerial Zimmermann R.
total ossicular replacement prosthesis (TORP). The study was a retrospective
chart review in a tertiary otologic referral center. A computerized otologic Published: Otology & Neurotology 2001, 22:582-589
database was used to identify 111 patients implanted with either a PORP or
TORP prosthesis. Audiograms were reviewed and air-bone gaps were calcu- Objective: The overall purpose of the study was the evaluation of the effi-
lated for each patient. The improvement of the average air-bone gap (ABG) cacy of Tübingen titanium prostheses (TTPs) for ossiculoplasty.
was 10.2 and 12.7 dB at 3 and 20 months after ossiculoplasty, respectively.
Sixty-six percent of patients (73/111) had a postoperative air-bone gap of Study Design: A two-part clinical study of 216 patients undergoing ossic-
20 dB or less. The ABG for the titanium PORP prosthesis was 14.3+/-9.7 uloplasty was performed. The first part was a prospective study using TTPs
dB, compared with 25.2+/-13.7 dB for the TORP prosthesis (P < 0.05). The (n = 114). The second part involved study of historical control patients (n =
ABG to within 20 dB or less was obtained in the PORP group in 77% of the 102) with gold and ceramic prostheses. Interventions: All patients under-
cases, versus 52% of the cases in the TORP group ( P < 0.05). Two extrusions went ossiculoplasty.
of the prostheses were observed at 17 and 20 months after surgery (1.8%).
Revision procedures for functional failure were carried out in 20 patients Main Outcome Measures: Measures included median air conduction
(18%). The rate of sensorineural hearing loss was 3.6%. The major factors thresholds and air-bone gaps.
influencing good audiometric results were the surgical procedure preserving
the external auditory canal and the presence of the stapes. The best hearing Results: All patients were per-protocol patients. When the air-bone gap
results were achieved when a PORP was used in an intact canal wall (ICW) “gold standard” (i.e., ≤ 10 dB) was investigated in the main speech spec-
procedure, and the worst hearing results were achieved when a TORP was trum, partial TTPs reached this level at 2 kHz in 44% (n = 22) and at 3 kHz
used in a canal wall down (CWD) procedure. The titanium Kurz prosthesis in 38% (n = 19). Gold and ceramics revealed significantly lower values.
has been an effective implant at our institution for ossicular reconstruction. Similar results were obtained for total prostheses. Differences for TTPs and
ceramics were statistically significant (Mann-Whitney U test, α = 5%).
Accoustomechanical properties of open Conclusion: The use of TTPs for ossiculoplasty is an efficient treatment method.
TTP titanium middle ear prostheses
®
Zenner H.P., Freitag H.- G., Linti C., Steinhardt U., Rodriguez
J. J., Preyer S., Mauz P.-S., Sürth M., Plank H., Baumann I., DUESSELDORF TYPE PROS THESIS
Lehner R., Eiber A.
Published: Hearing Research. 2004 Jun;192(1-2):36-46. Ossiculoplasty with titanium prostheses
DOI: 10.1016/j.heares.2004.02.004
Romer M., Vorburger M., Huber A.
Objective: The purpose of the study was to identify acoustcomechanical
properties of various biostable and biocompatible materials to create a Published: MEMRO 2006, 4th International Symposium on Middle Ear
middle ear prosthesis with the following properties: (i) improved handling Mechanics in Research and Otology: Selected Abstracts
including a good view of the head of the stapes or footplate and adjust-
able length, (ii) improved acoustical characteristics that are adequate for Objective: To determine the hearing results and the complication rate one
ossiculoplastic. The identified material should serve to build CE and FDA year after ossiculoplasty with the Kurz titanium system.
approved prostheses for clinical use in patients.
Material and Methods: A retrospective chart review of 82 procedures in 77
Methods: Test models made of Teflon, polyetheretherketone, polyethylen- patients. Included in the study were 36 Aerial-TORP and 46 Bell-PORP be-
terephtalate, polysulfone, gold, Al2O3 ceramics, carbon and titanium were tween October 2001 and October 2004. The air and bone conduction thresh-
investigated for their potential to fulfill the requirements. Acoustical prop- olds as well as the complication ratewere evaluated.
erties were investigated by laser Doppler velocimetry (LDV) in mechan-
ical middle ear models (MMM). Measured data were fed in to a recently Results: The mean preoperative air bone gap (ABG) was 32,9 (+/-13,4) dB.
created computer model of the middle ear (multibody systems approach, 16 (+/-7,2) months postoperatively the average ABG was 17,6 (+/-11,8) dB.
MBS). Using computer-aided design (CAD) measured and computed data The extrusion rate was 3/82 (3,7%). In one case (1,2%) the prosthesis per-
allowed creation and fine precision of titanium prostheses (Tubingen Tita- forated the stapes footplate and was dislocated into the vestibule without
nium Protheses, TTP). Their handling was tested in temporal bones. Acous- significant sensorineural hearing loss. The tympanic membrane reperfora-
tomechanical properties were investigated using the MBS and mechanical tion rate and the cholesteatoma recurrence rate was 3/82 (3,7%) and 1/82
middle ear models. (1,2%) respectively.
Main Outcome Measures: Input impedance, mass, stiffness, and geometry Conclusion: The Kurz titanium prosthesis system provides hearing success
of test models and prostheses were determined. Furthermore, their influence comparable with current ossiculoplasty studies and low complication rate.
on the intraprosthetic transfer functions and on coupling to either tympanic
membrane or stapes was investigated.
Results with Titanium Ossicular Reconstruction Prostheses
Results: Final results were FDA- and CE-approved filigreed titanium pros-
theses with an open head that fulfilled the four requirements detailed above. Gardner E. K., Jackson C. G., Kaylie D. M.
The prostheses (TTP) were developed in defined lengths of between 1.75
and 3.5 mm (partial) and 3.0 and 6.5 mm (total) as well as in adjustable Published: Laryngoscope 2004 Jan;114(1): 65-70.
lengths (TTP-Vario). DOI: 10.1097/00005537-200401000-00011
Conclusions: The results suggest acoustomechanical advantages of TTPs Objectives /Hypothesis: Despite the enthusiasm of recent short-term re-
because they combine a significantly low mass with high stiffness. In con- views, no center in the United States has published results meeting Amer-
trast to closed prostheses, the open head and filigreed design allow an ex- ican Academy of Otolaryngology-Head and Neck Surgery guidelines with
cellent view of the prosthesis foot during coupling to the head or footplate titanium-based prostheses. The purpose of the study was threefold. The first
of stapes, contributing to an improved intraoperative reliability of prosthesis purpose was to review results with a titanium prosthesis system in cases
coupling. meeting American Academy of Otolaryngology-Head and Neck Surgery

www.instrumentarium.ca
7