Case Study

Craniomaxillofacial Fracture Fixation Pilot Study

Brief

nanoMAG evaluated the biocompatibility, fixation, and healing of BioMg® magnesium-based alloy implants for craniomaxillofacial fracture fixation plates and screws in a load-bearing mandible model. This study was funded by the National Institutes of Health.

Bone fixation was monitored throughout the 4-week healing period using palpation and monitoring of mastication and feeding habits, as well as CT scans at 30 days post-op.

Bioabsorbable Magnesium Alloy Hardware

Figure 1a Mandibular 5-hole locking plate machined from BioMg® alloy.
Figure 1b Locking Screws machined from BioMg® alloy.

Implantation

Figure 2 BioMg® fixation plates and screws in place after mandibular osteotomy.

Bioabsorption 30 Days Post-Surgery

Figure 3a 30 days post-fixation CT scanning reconstruction showing start of healing at the lower border of the mandible and minor levels of Mg absorption (screw heads and distal half of the plate).
Figure 3b Interior view of mandible.
Figure 3c View from the base of the mandible with healing of the osteotomy visable.

Histological Analysis

Non-decalcified samples were embedded in polymer and five micrometer sections were cut and processed. Hematoxylin and eosin (H&E), Sanderson’s, Toluidine Blue, Goldner Trichrome and Mason’s Trichrome stainings were performed.

Figure 4a 30 days cross-section shows partial absorption of the implant and healing of the bone at the osteotomy.
Figure 4b 30 days histological analysis indicates healing at the osteotomy with healthy tissues and no signs of inflammation from the absorbing implant.

Follow-Up

Based on the success of this pilot study, nanoMAG has initiated, and is currently executing a 76 implant GLP study that will be used to support regulatory approvals. The study covers both biocompatibility and mechanical integrity at timepoints ranging from 30 days to beyond 12 months.

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