Internal Craniofacial Distraction with Biodegradable Devices: Early Stabilization and Protected Bone Regeneration

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Abstract
Internal craniofacial distraction has several advantages over distraction with external devices. The scars may be less conspicuous; the devices are buried and therefore easier for patients to tolerate; and the devices are more rigidly secured to bone, preventing uncontrolled rotation of the advancing segments. There are several types of internal devices. The Modular Internal Distraction System developed by one of the authors (S.R.C.) and Stryker-Leibinger, Inc. has had widespread use for midface distraction, but requires a substantial surgical procedure for device removal. This is justified in selected children with syndromic craniosynostosis, who frequently need secondary orbitocranial reconstruction at the conclusion of distraction with any type of device. It would be preferable to develop a device that would retain the positive characteristics of the Modular Internal Distraction system, while allowing easy removability. Moreover, the entire distraction procedure would benefit from a technique that would assist in bone regeneration within the distraction gap. Such a biodegradable, stabilizing device may enable early explantation, accelerating the recovery period, while providing fixation of the distraction gap and protected bone regeneration. Accordingly, we have developed a new, biodegradable distraction device with Macropore, Inc. that may be used with the Modular Internal Distraction system to permit easy removability of the device without the need for a large operation for exposure. Second, we have developed a biodegradable stabilizer that permits earlier removal of the distraction device while providing simultaneous fixation and protected bone regeneration. Last, we have demonstrated the feasibility of midcourse correction of the distraction procedure, should this be necessary for whatever reason.

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