Self-crimping superelastic nitinol prosthesis and malleostapedotomy: a temporal bone study

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Neurosurgery

Background:

• Malleostapedotomy involves implanting prostheses to restore hearing.
• Nitinol prostheses offer unique superelastic properties for otologic surgery.
• Current techniques may have limitations in adaptability and implantation time.

Purpose of the Study:

• To compare the application results of two types of superelastic nitinol prostheses.
• To evaluate the efficacy of a modified self-crimping nitinol prosthesis (mSC-PTFE) against standard nitinol and manual crimping prostheses.

Main Methods:

• A human temporal bone study was conducted with 15 specimens.
• Three prostheses were implanted: manually crimping polytetrafluoroethylene (MC-PTFE), nitinol self-crimping polytetrafluoroethylene (SC-PTFE), and modified nitinol self-crimping polytetrafluoroethylene (mSC-PTFE).
• Implantation time, attachment quality, stapes footplate positioning, and vestibule protrusion were assessed.

Main Results:

• The mSC-PTFE prosthesis demonstrated a statistically significant reduction in mean operation time compared to both SC-PTFE and MC-PTFE prostheses (P < .0001).
• Piston protrusion into the vestibule was highly reproducible across all tested prostheses.
• The modified nitinol prosthesis (mSC-PTFE) has a greater length (7.75 mm) than the other two (7 mm).

Conclusions:

• The mSC-PTFE superelastic nitinol prosthesis offers advantages due to its increased length, accommodating diverse anatomical variations.
• Its self-crimping mechanism eliminates distortion risks associated with manual crimping and reduces operative time.
• This modified prosthesis presents a promising advancement for malleostapedotomy procedures.