A modified prosthesis head for middle ear titanium implants--experimental and first clinical results

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Surgical Innovation

Background:

• Ossicular chain defects pose challenges in otosurgery, with prosthesis dislocation leading to poor hearing outcomes.
• Effective coupling between the prosthesis head and tympanic membrane is crucial for successful type III tympanoplasty.

Purpose of the Study:

• To evaluate a new titanium total ossicular replacement prosthesis (TORP) design aimed at minimizing short-term postoperative dislocation.
• To assess the stability and hearing results of a modified TORP with a spiked head.

Main Methods:

• A prospective study involving experimental testing and clinical application of a modified titanium TORP with a spiked head.
• Comparison of lateral holding force against common TORP heads and analysis of postoperative hearing via air-bone gap (ABG) in 35 patients.

Main Results:

• The modified prosthesis head demonstrated significantly higher lateral holding force (134 mN vs. 92 mN).
• No prosthesis dislocations were observed in the study or control groups.
• Postoperative ABGs were comparable between the modified and conventional TORPs (20.9 dB vs. 18.6 dB), with no statistically significant difference.

Conclusions:

• The modified TORP design with a spiked head increases lateral holding force, reducing the risk of dislocation.
• Hearing results with the new prosthesis are comparable to conventional types.
• Larger studies are needed to confirm the advantages of the modified prosthesis over conventional ones.