A clinical pilot study on preformed autologous ossicles. I.

Area of Science:

• Biomaterials Engineering
• Regenerative Medicine
• Otolaryngology

Background:

• Autologous bone grafts are crucial for ossicular chain reconstruction in middle ear surgery.
• Previous animal studies demonstrated bone formation within titanium molds in vivo.
• The feasibility of this technique in humans for otologic applications remained unproven.

Purpose of the Study:

• To assess the potential of a titanium mold system for generating autologous bone in humans.
• To determine the suitability of the generated bone for ossiculoplasty in patients with ossicular defects.

Main Methods:

• A custom titanium mold with two chambers was implanted in the proximal tibial metaphysis of 5 patients for 6 months.
• Bone formation within the molds was evaluated macroscopically, histologically, and microradiologically.
• The stability and suitability of the harvested bone for ossiculoplasty were assessed.

Main Results:

• Bone formation was observed in 7 out of 10 implanted chambers.
• Two of the bone samples were found to be stable and suitable for ossiculoplasty.
• Histological analysis revealed a structure consistent with cortical and spongy bone, including marrow and hematopoietic cells, mirroring animal experiment findings.

Conclusions:

• Titanium molds can successfully induce autologous bone formation in human tibial implants.
• This technique shows promise for generating patient-specific bone grafts for ossicular reconstruction.
• Further research is warranted to optimize the process and clinical application for ossiculoplasty.