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Related Experiment Video

Updated: Jun 4, 2026

Techniques of Endoscopic Ossiculoplasty
09:07

Techniques of Endoscopic Ossiculoplasty

Published on: January 26, 2024

Good manufacturing practices--grade preformed ossicular prostheses from banked bone via computer numerically

Stefano Berrettini1, Luca Bruschini, Cesare Stefanini

  • 1Otology-Cochlear Implants Unit, Neuroscience Department, University of Pisa, Italy.

The Annals of Otology, Rhinology, and Laryngology
|March 5, 2011
PubMed
Summary

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Researchers fabricated highly accurate ossicular replacement prostheses (ORPs) from banked bone using CNC micromilling. These biocompatible ORPs offer a promising alternative to synthetic implants for hearing restoration.

Area of Science:

  • Biomaterials Engineering
  • Tissue Engineering
  • Otolaryngology

Background:

  • Synthetic ossicular replacement prostheses (ORPs) are widely used but lack biological integration.
  • Biological alternatives often face challenges with standardization and availability.
  • There is a need for biocompatible ORPs with the precision of synthetic devices.

Purpose of the Study:

  • To fabricate clinical-grade ossicular replacement prostheses (ORPs) from decellularized banked cortical bone.
  • To achieve high dimensional accuracy and detailed replication comparable to synthetic implants.
  • To evaluate the suitability of these novel prostheses for ossicular chain reconstruction.

Main Methods:

  • Utilized computer numerically controlled (CNC) ultraprecision micromilling to shape banked femoral compact bone into partial and total ORPs.

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Last Updated: Jun 4, 2026

Techniques of Endoscopic Ossiculoplasty
09:07

Techniques of Endoscopic Ossiculoplasty

Published on: January 26, 2024

  • Adhered to Good Manufacturing Practices (GMP) throughout the fabrication process.
  • Conducted dimensional, weight, surface characterization, and histologic analysis of the produced ORPs.

    • Main Results:

    • Successfully fabricated banked-bone ORPs with high dimensional accuracy.
    • Achieved precise weight control, with partial ORPs averaging 31.2 ± 0.6 mg and total ORPs averaging 69.3 ± 0.7 mg.
    • Histologic analysis confirmed suitable extracellular matrix compactness for ossicular chain replacement, with surface finishes at micro/nanoscale.

    Conclusions:

    • Demonstrated the feasibility of fabricating novel banked-bone ORPs with exceptional dimensional accuracy.
    • These prostheses aim to combine the reproducibility and biosafety of synthetic implants with the biocompatibility of biological replacements.
    • The developed banked-bone ORPs represent a promising advancement in tissue-engineered solutions for hearing restoration.