Ossiculoplasty with polymaleinate ionomeric prosthesis

Area of Science:

• Otolaryngology
• Biomaterials Science
• Audiology

Background:

• Concerns regarding viral transmission via traditional middle ear implants necessitate biocompatible alternatives.
• Polymaleinate ionomers, established dental materials, are now utilized for ossicular replacement prostheses.
• A multicenter prospective clinical trial was conducted to evaluate these novel implants.

Purpose of the Study:

• To assess the preliminary surgical outcomes and audiometric data of polymaleinate ionomer middle ear prostheses.
• To review the ease of surgical contouring and material handling of these new implants.
• To provide initial insights into the effectiveness of ionomeric prostheses for partial and total ossicular replacement.

Main Methods:

• A multicenter prospective clinical trial involving 92 patients implanted with polymaleinate ionomer prostheses.
• Surgical evaluation of prosthesis handling, including contouring and resistance to shattering.
• Preliminary audiometric assessment of air-bone gaps in 80 patients (59 partial ossicular replacement prostheses, 21 total ossicular replacement prostheses) with follow-up ranging from 3 to 22 months.

Main Results:

• Ionomeric prostheses demonstrated ease of contouring and were not prone to shattering during surgery.
• For partial ossicular replacement prostheses (n=59), 25% achieved air-bone gaps of 0-10 dB, and 34% achieved 11-20 dB.
• For total ossicular replacement prostheses (n=21), 29% achieved air-bone gaps of 0-10 dB, and 29% achieved 11-20 dB.

Conclusions:

• Polymaleinate ionomer prostheses offer favorable surgical characteristics for middle ear reconstruction.
• Preliminary audiometric results suggest potential efficacy for both partial and total ossicular replacement.
• While long-term outcomes require further investigation, these ionomeric implants represent a promising biocompatible alternative.