Clinical Evaluation of an Unsintered Hydroxyapatite/Poly-L-Lactide Osteoconductive Composite Device for the Internal Fixation of Maxillofacial Fractures

Abstract

Introduction:OSTEOTRANS MX (Takiron Co, Ltd, Osaka, Japan) is a resorbable osteosynthetic material composed of an unsintered hydroxyapatite/poly-l-lactide composite, and its osteoconductive capacity has been documented. The authors here report their clinical experience using OSTEOTRANS MX.Methods:The authors treated 35 patients (19 men, 16 women; age, 14–88 years; mean ± standard deviation, 38.4 ± 19.9 years) with maxillofacial fractures. The authors used standard surgery to stabilize fractures in all patients, fitting resorbable plates (thickness, 1.0 or 1.4 mm) and screws (diameter, 2 mm) according to Arbeitsgemeinschaft für Osteosynthesefragen/Association (AO) for the Study of Internal Fixation guidelines.Results:All patients eventually achieved satisfactory healing with favorable restoration of form and function without foreign body reaction. Complications occurred in 3 patients—plate exposure in 2 and discomfort in 1. However, fracture sites healed in all patients. Scanning electron microscopy revealed that the devices bonded directly to the bone without interposition of nonmineralized tissue.Conclusion:OSTEOTRANS MX is a useful material with few complications. Its osteoconductive bioactivity is advantageous for the early functional improvement of maxillofacial fractures.

Precision of Post-Traumatic Orbital Reconstruction Using Unsintered Hydroxyapatite Particles/Poly-L-Lactide Composite Bioactive/Resorbable Mesh Plate with and without Navigation: A Retrospective Study

“…This new product is a composite of fine particles of u-HA and PLLA. As we recently reported, this material has clinical advantages for maxillofacial surgery 25) , particularly for midfacial-to-periorbital fracture fixation for reconstruction 10) , with good clinical results, even in long-term follow-up 13) . Its mechanical strength closely approximates that of cortical bone, it has osteoconductive properties, and it makes direct contact with the bone.…”

“…Resorbable osteosynthesis technology is constantly evolving to enhance bioresorbability and bioactive osteoconductivity with new compositions of materials to improve in the situ behavior. In particular, OSTEOTRANS MX ® (Takiron Co., Ltd., Osaka, Japan), also called Super FIXSORB MX ® in Japan, is a bioactive and totally resorbable maxillofacial osteosynthetic bone fixation material that has been reported to exhibit clinical efficacy with long-term stability [12][13][14] . It consists of a composite of fi ne particles of unsintered hydroxyapatite (u-HA) and poly-L-lactide (PLLA).…”

Feasibility of Single Folded Unsintered Hydroxyapatite Particles/Poly-L-Lactide Composite Sheet in Combined Orbital Floor and Medial Wall Fracture Reconstruction

“…In this report, u-HA/PLLA composite effectively could meet all the ideal characteristics of an orbital implant material 1,2,4,[10][11][12][13][14] .…”

“…The ground-breaking osteoconductive and bioactive properties of these composites allow them to fuse directly with bone. Thus, u-HA/PLLA composites are of interest as a candidate material for orbital wall reconstruction because of their advantageous physical properties, high levels of customizability and control, and sufficient stability to support the orbital content 1,13,14) . Furthermore, the tack fixation technique applied with thin u-HA/PLLA composite sheets in reconstructive surgery for large orbital wall fractures could be useful in combined orbital floor and medial wall defect fracture repair 1) .…”

“…Super Fixsorb-MX® (Japanese trade name; also known as OSTEOTRANS-MX overseas; Takiron Co. Ltd., Japan), which is a composite of fine unsintered hydroxyapatite (u-HA) particles and carbonated ions combined with poly-L-lactide (PLLA; u-HA/ PLLA), is a promising bioactive, osteoconductive, and completely resorbable osteosynthetic bone fixation and maxillofacial reconstructive material that has recently drawn attention for its long-term clinical stability in maxillofacial skeletal fixation and reconstruction 1,13,14) . The ground-breaking osteoconductive and bioactive properties of these composites allow them to fuse directly with bone.…”