The Clinical Feasibility of Newly Developed Thin Flat-Type Bioresorbable Osteosynthesis Devices for the Internal Fixation of Zygomatic Fractures

Abstract

Introduction:In recent years, bioresorbable plates have undergone remarkable development. However, there has been no attendant improvement in their strength, because strength requires thickness, and complications such as palpability are related to the thickness of bioresorbable plate systems. In this clinical study, we compared the surgical management of zygomatic fractures using newly developed thinner bioresorbable materials or conventional titanium miniplates.Methods:Twelve patients with zygomatic fractures were randomly divided equally into 2 groups (6 with new bioresorbable osteosynthesis materials and 6 with standard titanium miniplates). Using computed tomography, we evaluated the thickness of the soft tissue and plate at the zygomaticofrontal sutures in each patient with the help of detailed radiographic computed tomography data at 6 months postoperatively. We compared the amount of soft-tissue volume increase between the uninjured healthy and injured operated sides in each patient.Results:Both groups eventually achieved satisfactory healing, with a favorable restoration of form and function and without any complications, including palpability. The amount of soft-tissue volume increase at the operated side relative to the uninjured healthy side using new thin bioresorbable plates was 131.1% (range: 101.5–165.8). On the other hand, that of titanium miniplates was 126.4% (range: 102.2–167.6). There was no statistically significant difference (P > 0.05).Conclusion:This newly developed thinner flat-type bioresorbable plate system could be considered clinically useful in the treatment of zygomatic fractures even in easily palpated areas, such as the infraorbital rim or zygomaticofrontal sutures, without any healing differences in skeleton as compared with conventional titanium miniplates.

Overview of innovative advances in bioresorbable plate systems for oral and maxillofacial surgery

“…The resulting metabolites should not cause any local or systemic problems. Additionally, the amount of material required must be small, and the material itself must be flexible enough to be applied at various maxillofacial bone sites [16] , [17] , [18] , [19] . These aforementioned three resorbable materials, PGA, PLLA, and PDLA, have been commonly well introduced for the products [13] , [17] ( Fig.…”

“…In a clinical setting, the total resorption time of PLLA appears to be over 3.5 years [27] , [28] . Two PLLA devices, FixsorbMX ® (TEIJIN Medical Corp., Osaka, Japan) and GrandFix ® (GUNZE, Kyoto, Japan), have been used in maxillofacial bone surgery [13] , [16] . Reported problems include insufficient intensity of materials, foreign-body reactions, and a late-degradation tissue response [16] , [27] , [28] .…”

“…On the other hand, the limitations of biodegradable osteofixation implants are associated mainly with their mechanical properties [13] , [14] , [16] ; they are weaker than conventional such titanium metal implants, leading to low confidence levels regarding the stability of reduced fractures [13] , [16] . Biocompatibility may be another limitation of these materials as they can provoke adverse tissue responses that have characteristics of an inflammatory, bacterial foreign-body reaction [16] , [17] .…”

“…However, bioresorbable implant materials for oral and maxillofacial osteosynthetic applications are currently becoming more common. These materials are safe, effective, and sufficiently flexible for use at many maxillofacial boney surgical sites [13] , [14] , [15] , [16] , [17] . Numerous clinical studies and several review articles have documented the feasibility of bioresorbable materials and these osteofixation plate and screw systems, showing comparable results between the use of resorbable and titanium plates and screws in various maxillofacial surgeries.…”

“…Numerous clinical studies and several review articles have documented the feasibility of bioresorbable materials and these osteofixation plate and screw systems, showing comparable results between the use of resorbable and titanium plates and screws in various maxillofacial surgeries. Furthermore, novel products and feasible modified systems have been introduced for clinical applications [16] , [18] , [19] .…”