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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

Authors :
Barzi Gareb
Nico B. van Bakelen
Léon Driessen
Pieter Buma
Jeroen Kuipers
Dirk W. Grijpma
Arjan Vissink
Ruud R.M. Bos
Baucke van Minnen
Source :
Bioactive Materials, Vol 17, Iss , Pp 439-456 (2022)
Publication Year :
2022
Publisher :
KeAi Communications Co., Ltd., 2022.

Abstract

Applying 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 osteosynthesis 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.

Details

Language :
English
ISSN :
2452199X
Volume :
17
Issue :
439-456
Database :
Directory of Open Access Journals
Journal :
Bioactive Materials
Publication Type :
Academic Journal
Accession number :
edsdoj.78fec0b444d44a39a7456862c64dbf7
Document Type :
article
Full Text :
https://doi.org/10.1016/j.bioactmat.2022.01.015