Clinical Articles
The fate of resorbable poly-L-lactic/polyglycolic acid (Lactosorb) bone fixation devices in orthognathic surgery*,**,*,**,

https://doi.org/10.1053/joms.2001.19267Get rights and content

Abstract

Purpose: The aim of this study was to evaluate the long-term outcome of resorbable poly-L-lactic/polyglycolic acid (PLLA-PGA) bone fixation devices used for fixation of maxillary and mandibular osteotomies. Materials and Methods: Twelve patients were postoperatively evaluated. Eight patients who had undergone bilateral sagittal split mandibular osteotomies that had been fixed with PLLA-PGA screws were followed-up for up to 2 years postoperatively with radiographs. One of these patients underwent a bone biopsy for detailed histologic evaluation of the screw fixation sites. Two patients who had undergone mandibular symphyseal osteotomies were also radiographically evaluated at 18 months to 2 years postoperatively. Two patients who had Le Fort I osteotomies fixed with PLLA-PGA plates and screws underwent open exploration of the operated sites for visual examination. Results: All 8 mandibular osteotomy patients showed radiographic screw hole lucency immediately after surgery that remained unchanged in the first year after surgery. By 18 months postoperatively, all 48 screw holes showed near or complete trabecular bone fill. The bone biopsy of one screw hole at 2 years postoperatively showed complete fill with normal trabecular bone. No residual polymer material or fibrous scar was seen. The mandibular symphyseal sites showed complete elimination of all screw holes by 2 years postoperatively, with only faint evidence of intraosseous tunnels. The maxillary sites showed complete bone healing along the osteotomies and no evidence of residual fixation material or bone defects in the screw holes. No communication with the maxillary sinus was seen in the fixation sites. Conclusion: This orthognathic patient series showed complete resorption of the PLLA-PGA fixation devices without osteolysis in maxillary and mandibular bone sites by 18 to 24 months after surgery. This is partially a US government work. There are no restrictions on its use.

Section snippets

Fixation devices

The bone fixation devices used were composed of an 82% poly-L-lactic acid/18% polyglycolic acid (PLLA-PGA) copolymer (LactoSorb, Walter Lorenz Surgical, Jacksonville, FL) that has been shown to be substantially amorphous and undergo complete resorption in experimental models between 9 to 15 months after surgery depending on the size and location of the devices.10, 11 The mandibular ramus osteotomies were fixed with six 2.5-mm × 13- to 15-mm bicortical screws placed at the superior border.3 The

Mandibular sagittal split osteotomies

Of the 8 patients evaluated, all showed 3 distinct circular radiolucencies at the fixation sites in each mandibular ramus. By 1 year postoperatively, the radiolucency of the screw holes had not significantly changed, showing neither enlargement nor an increased amount of radiolucency. By 2 years postoperatively, the screw holes had undergone a significant change in their radiographic appearance. Thirty-three of the 48 screw holes (68.8%) were no longer discernible, having been completely

Discussion

The real value of resorbable polymeric bone fixation devices lies only partly in their capability to adequately fix the craniomaxillofacial bones after either traumatic injuries or elective osteotomies. In addition to providing bony stability and normal healing, they also must be completely resorbed by the body postoperatively without any adverse local tissue side effects (eg, foreign body reactions) that may cause local deformity and pain or necessitate the need for secondary surgery for their

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†Chief, Department of Oral and Maxillofacial Surgery, Nellis Air Force Base, Las Vegas, NV.

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‡Assistant Professor of Plastic Surgery, Division of Plastic Surgery, Indiana University School of Medicine, Indianapolis, IN.

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The views expressed in this article are those of the authors and do not reflect the official policy or position of the Department of Defense or the US Government.

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Address correspondence and reprint requests to Dr. Edwards: Oral and Maxillofacial Surgery Associates, 880 Westfall Rd, Rochester, NY 14618; e-mail: [email protected]

This is partially a US government work. There are no restrictions on its use.

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