gms | German Medical Science

In spite of the large number of prostheses on the market, there has been a paucity of long term comparative studies on different ossiculoplasty materials.

The present study compares the medium term outcome (2-year post-operation) of ossiculoplasty based on the random allocation of titanium (Ti) and hydoxyapatite (HA) prostheses. Between 2002 and 2007, 94 patients were recruited for the study. Only cases of chronic otitis media were included.

Of the 94 ossiculoplasties, 29 were Ti TORP, 19 were Ha TORP, 20 were Ti PORP and 26 were Ha PORP. The basic patient characteristics of the 2 groups of PORPs and TORPs were comparable. The mean hearing gain in the Ha PORP and the Ti PORP cohorts were 14.30 dB and 15.10 dB respectively. The mean hearing gain in the Ha TORP and Ti TORP cohorts were 13.52 dB and 13.48 dB respectively. There was no significant difference between Ha and Ti for both PORPs and TORPs. There was also no significant difference in their extrusion rate.

A power analysis using the data from the present study indicated that a sample size of 150-200 cases are needed to detect a difference of 5 dB between the 2 types of materials for both the PORPs and TORPs. The current study has highlighted many factors that make randomized controlled studies impractical in comparing different ossicular prostheses or surgical techniques. The sample size required is too large for it to be carried out by a single centre. The medium and long term outcomes require high patient compliance for follow-up. It is also difficult to standardise the surgical approach if several surgeons are involved in a multi-centre study. One should look at alternative ways of comparing different prostheses, and it may depend on what parameter one chooses to study.