First Report of an Innovative Angle Stable, Ultrasonic-Guided, Resorbable Osteosynthesis System for the Treatment of Midfacial Trauma

Article Outline

• Statement
• Materials and Methods
• Method of Data Analysis
• Results
• Conclusion
• References
• Copyright

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Statement 

For the conventional surgical trauma treatment of midfacial-, zygoma fractures, orbital floor fractures, fractures of the anterior wall of frontal sinus and various other indications (craniosynostosis, TMJ - Discfixation) resorbable as well as metallic (Titan) osteosynthesis materials are in use. Common resorbable plate systems require the preparation of threads and can therefore hamper a successful outcome of the reposition due to dislocation. The application of an innovative ultrasonic guided resorbable osteosynthesis system (SonicWeld) that is based on the principle of angle-stability is an approach to overcome this problem.

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Materials and Methods 

The angle stability is based on the melting and bonewelding procedure of the resorbable material (PDLLA). The well known reduced mechanical properties of resorbable materials can be overcome by this stable plate–pin-complex, additionally by means of the special designed pin structure the pin material welds into the cortico-spongious microsurface of the bone induced by ultrasound. Compared to resorbable screws these innovative three-dimensional pins provide a significantly more stable connection.

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Method of Data Analysis 

Intraoperative handling is evaluated according to a defined protocol from all 15 surgeons who were involved in this clinical trial. The postoperative follow-up comprises clinical, functional, esthetical, and radiological findings, presented using descriptive statistics.

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Results 

We applied SonicWeld in 72 patients, in some cases combined with metallic osteosynthesis materials. We observed a shorter duration of the interventions due to shorter time required for osteosynthesis. In four patients a local inflammation of the mucosa or the skin covering the plate-pin-complex occurred at the zygomaticoalveolar crest. The SonicWeld systems requires only a short training period for this new pin insertion method for the surgeon.

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Conclusion 

For the first time we achieve based on the melting and welding process an angle stable osteosynthesis with a resorbable osteosynthesis system. Therefore this concept can be expected to have an impact on the treatment of fractures also in regions with higher mechanical load.

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References 

1. Pilling E, Meissner H, Jung R, Koch R, Loukota R, Mai R, et al. An experimental study of the biomechanical stability of ultrasound-activated pinned (SonicWeld Rx((R))+Resorb-X((R))) and screwed fixed (Resorb-X((R))) resorbable materials for osteosynthesis in the treatment of simulated craniosynostosis in sheep. Br J Oral Maxillofac Surg. 2007;Jan 31; 17275145
2. Pilling E, Mai R, Theissig F, Stadlinger B, Loukota R. An experimental in vivo analysis of the resorption to ultrasound activated pins (Sonic weld((R))) and standard biodegradable screws (ResorbX((R))) in sheep. Br J Oral Maxillofac Surg. 2007;Jan 9