Comparison of Titanium vs. Polycel Total Ossicular Replacement Prosthesis

Document Type: Original

Authors

1 Otorhinolaryngology Research Centre, Shiraz University of Medical Sciences, Shiraz, Iran.

2 Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran.

Abstract

Introduction:
Even though modern technology progresses so rapidly, annals of otology are replete with so many challenging article, which often compare various types of prosthesis. Since there has not been a prospective randomized clinical trial study which compares the hearing result of total ossicular replacement prosthesis made of Titanium with omega connector and Polycel in the literature, we decided to perform a study encompassing this issue.
 
Materials and Methods:
105 patients, who were in the 2nd stage of their operation and who needed total ossicular replacement prosthesis, were included in this prospective single blind randomized clinical trial study. Patients were classified in two groups: titanium Kurz (TTP™ -Vario system, Kurz GmbH, Dusslingen, Germany) with omega connector and Polycel (Sheehy Plastipore Polycel, Medtronic Xomed Inc). The duration of the follow up was 6-12 months. In order to evaluate hearing results, pure tone audiometric in 0.5, 1, 2, and 4 kHz were checked. In addition, speech reception threshold was recorded. A successful surgery was defined as having a postoperative air–bone gap within 20 dB.
 
Results:
We accomplished successful hearing in 64.4% of patients with titanium and 65% of patients with a Polycel prosthesis.Improvement in speech reception threshold was 11.5 dB in the titanium group and 13 dB in the Polycel group. In other words, there was no significant difference between the two groups. In addition, air-bone gap improvement after ossiculoplasty was 11.2 dB in the patients with a titanium prosthesis and 12.4 dB in the Polycel group. In fact, the difference was not significant.
 
Conclusion:
We found that both the titanium and the Polycel prosthesis improve speech reception threshold and air-bone gap closure in a similar manner.

Keywords

Main Subjects


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