Resorbable PLLA-PGA Plate and Screw Fixation in Pediatric Craniofacial Surgery: Clinical Experience in 1883 Patients

Abstract

The need to provide rigid bony fixation in the surgical treatment of craniofacial deformities has inspired an on-going evolution of surgical innovations and implants. Because of the young age of many treated craniosynostosis patients and the unique pattern of cranial vault growth, the extensive implantation of metal devices is potentially problematic. The use of resorbable plate and screw devices offers all of the benefits of rigid fixation without many of their potential risks. Since the introduction of resorbable plate and screw devices in 1996, tens of thousands of craniofacial patients have received implants, but long-term results from a large series have yet to be reported. A combined prospective and retrospective analysis was done on 1883 craniosynostosis patients under 2 years of age treated by 12 surgeons from seven different geographic locations over a 5-year period who used the same type of resorbable bone fixation devices (poly-L-lacticpolyglycolic copolymer). Specifically, the incidence of postoperative infection, fixation device failure, occurrence of delayed foreign-body reactions, and the need for reoperation resulting from device-related problems were determined. Technical difficulties and trends in device use were also noted. From this series, significant infectious complications occurred in 0.2 percent, device instability primarily resulting from postoperative trauma occurred in 0.3 percent, and self-limiting local foreign-body reactions occurred in 0.7 percent of the treated patients. The overall reoperation rate attributable to identifiable device-related problems was 0.3 percent. Improved bony stability was gained by using the longest plate geometries/configurations possible and bone grafting any significant gaps across plated areas that were structurally important. The specific types of plates and screws used evolved over the study period from simple plates, meshes, and threaded screws to application-specific plates and threadless push screws whose use varied among the involved surgeons. This report documents the safety and long-term value of the use of resorbable (LactoSorb) plate and screw fixation in pediatric craniofacial surgery in the infant and young child. Device-related complications requiring reoperation occurred in less than 0.5 percent of the implanted patients, which is less frequent than is reported for metallic bone fixation. Resorbable bone fixation for the rapidly growing cranial vault has fewer potential complications than the traditional use of metal plates, screws, and wires.

Spherical calcium phosphate nanoparticle fillers allow polymer processing of bone fixation devices with high bioactivity

“…screws or plates [1, [4][5][6] in oral and maxillofacial surgery [7]. Poly(lactide-co-glycolide) (PLGA) is one of the most often used biodegradable synthetic polymers [8].…”

Intraoperative tissue expansion in the surgical correction of craniosynostosis

“…The volume increase leads to an inherent increase in surface area, and because the soft tissue envelope remains unaltered, incision closure during this procedure can be challenging due to the high degree of tension, sometimes leading to the aforementioned wound healing difficulties. In fact, the degree of tension can be so high that some have been concerned about compression forces on the newly constructed calvarial vault postoperatively (11). We propose that intraoperative tissue expansion in the subgaleal plane is a means to reduce the tension on the closure and thereby reduce the risk of postoperative wound healing complications.…”

The cranial orbital buttress technique for nonsyndromic unicoronal and metopic craniosynostosis

“…3 In a review of the use of resorbable plates and screws in 1883 craniofacial surgical cases, Eppley et al reported device failure from breakage of the plates that required reoperation in the postoperative period (0.3%) and delayed foreign body reactions (0.7%) that resulted in swelling and/or cyst formation. 6 Higher complication rates due to resorbable plates and screws were reported by Pearson et al (17%) 22 and Sanger et al (15.3%), including palpable plates and an instance in which the absorbable plates were surgically removed due to erythema. 26 Furthermore, there are the inherent challenges in nearly all surgeries and operative techniques: blood loss, extended surgical times, narrow application, or lack of an aesthetically acceptable result.…”