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Biocompatibility and degradation comparisons of four biodegradable copolymeric osteosynthesis systems used in maxillofacial surgery: A goat model with four years follow-up

引用

Bioactive Materials 2022年第11期7卷 439-456页

作者： Barzi Gareb nico bvan bakelen Leon Driessen Pieter Buma Jeroen Kuipers Dirk W.Grijpma Arjan Vissink Ruud R.M.Bos Baucke van Minnen University of Groningen University Medical Center GroningenDepartment of Oral and Maxillofacial SurgeryHanzeplein 19713 GZP.O.Box 300019700 RBGroningenthe Netherlands Radboud University Medical Center Radboud Institute for Molecular Life SciencesOrthopaedic Research LabHoutlaan 46525 XZP.O.Box 91026500 HCNijmegenthe Netherlands University of Groningen University Medical Center GroningenDepartment of Biomedical Sciences of Cells and SystemsHanzeplein 19713 GZP.O.Box 300019700 RBGroningenthe Netherlands University of Twente TechMed CentreDepartment of Biomaterials Science and TechnologyDrienerlolaan 57522 NBP.O.Box 2177500 AEEnschedethe Netherlands

pplying biodegradable osteosyntheses avoids the disadvantages of titanium osteosyntheses. However, foreign-body reactions remain a major concern and evidence of complete resorption is lacking. This study compared the physico-chemical properties, histological response and radiographs of four copolymeric biodegradable osteo-synthesis systems in a goat model with 48-months follow-up. The systems were implanted subperiosteally in both tibia and radius of 12 Dutch White goats. The BioSorb FX [poly(70LLA-co-30DLLA)], Inion CPS [poly([70–78.5] LLA-co-[16–24]DLLA-co-4TMC)], SonicWeld Rx [poly(DLLA)], LactoSorb [poly(82LLA-co-18GA)] systems and a negative control were randomly implanted in each extremity. Samples were assessed at 6-, 12-, 18-, 24-, 36-, and 48-month follow-up. Surface topography was performed using scanning electron microscopy (SEM). Differential scanning calorimetry and gel permeation chromatography were performed on initial and explanted samples. Histological sections were systematically assessed by two blinded researchers using (polarized) light microscopy, SEM and energy-dispersive X-ray analysis. The SonicWeld Rx system was amorphous while the others were semi-crystalline. Foreign-body reactions were not observed during the complete follow-up. The SonicWeld Rx and LactoSorb systems reached bone percentages of negative controls after 18 months while the BioSorb Fx and Inion CPS systems reached these levels after 36 months. The SonicWeld Rx system showed the most predictable degradation profile. All the biodegradable systems were safe to use and well-tolerated (i.e., complete implant replacement by bone, no clinical or histological foreign body reactions, no [sterile] abscess formation, no re-interventions needed), but nanoscale residual polymeric fragments were observed at every system’s assessment.

关键词： Biocompatible materials Absorbable implants Polymers Orthopaedic fixation devices Reconstructive surgical procedures Fracture fixation

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