Development of a novel PLDLA/β-TCP composite-based biodegradable anterior cervical plate and screw system.

Abstract

We investigated the effectiveness and safety of a new composite-based biodegradable anterior cervical plate/screw (ACPS) system for the anterior cervical discectomy and fusion (ACDF) fixation. A biocomposite in combination with 30 wt% β-tricalcium phosphate (β-TCP; a biodegradable ceramic having osteoconductive ability) and 70 wt% poly-l/d-lactide copolymer (PLDLA; a biodegradable polymer) was developed and used in the ACPS device, comprising one plate and four screws for fixation. Based on a literature review, a clinically required period of performance maintenance was set as 16 weeks, and to verify the performance for a period of 16 weeks or more, the test was conducted for 26 weeks. Following ISO 13781:2017 testing protocols, an in vitro degradation test was performed to verify the performance and evaluate the decomposition characteristics of the biodegradable ACPS system. Using an animal model as a preclinical investigation, the prepared ACPS device was implanted into five mongrel dogs weighing over 30 kg to evaluate the detachment prevention effect of the ACPS system on polyether ether ketone (PEEK) cage after ACDF. By week 26, the molecular weight was decreased by 45.35% for the plate and 52.56% for the screw; the bending strength of the plate was decreased by approximately 26.2% when compared with the initial stage. The torsional yield strength and pullout strength of the screw was increased by 52.31% and 5.3%, respectively by week 2 and then subsequently decreased until week 26. No detachment or dislocation of the inserted PEEK cage was observed for 26 weeks in vivo study. These findings recommend that the ACPS system might be a promising biodegradable tool for the fixation of interbody implants and supporting the fusion in an ACDF model. Furthermore, additional clinical trials are planned for the future.