Fabrication of PLLA/C3S Composite Membrane for the Prevention of Bone Cement Leakage

Abstract

Kyphoplasty is an important treatment for stabilizing spine fractures due to osteoporosis. However, leakage of polymethyl-methacrylate (PMMA) bone cement during this procedure into the spinal canal has been reported to cause many adverse effects. In this study, we prepared an implantable membrane to serve as a barrier that avoids PMMA cement leakage during kyphoplasty procedures through a hybrid composite made of poly-l-lactic acid (PLLA) and tricalcium silicate (C 3 S), with the addition of C 3 S into PLLA matrix, showing enhanced mechanical and anti-degradation properties while keeping good cytocompatibility when compared to PLLA alone and most importantly, when this material design was applied under standardized PMMA cement injection conditions, no posterior wall leakage was observed after the kyphoplasty procedure in pig lumbar vertebral bone models. Testing results assess its effectiveness for clinical practice.2 of 17 the created cavity after balloon inflation during the kyphoplasty procedure [10]. Following which the balloon is re-inserted and inflated, creating a cement shell or a cement membrane around the inner walls of the created cavity, and another batch of cement was mixed and injected into the remaining cavity thereafter with limited cement leakage possibility from initial cement setting. Although this double cement application with PMMA as the cement anti-leakage shell or membrane has demonstrated its efficacy in clinical trial during the kyphoplasty procedure [11], the long term complications might be devastating due to PMMA presence on the bone cement surface [9], which makes the development of a new material design for anti-leakage membrane necessary. For example, Tetsushi Taguchi et al. had fabricated the reactive poly(vinyl alcohol) (PVA) membrane for the prevention of bone cement leakage with good potential for implantable balloon kyphoplasty, but further investigations on its clinical efficiency are still in progress [12].On the other hand, polymeric membranes fabricated from a single material more often have limited biological performance compared to the use of hybrid biomaterials composed of biodegradable synthetic polymers and inorganic materials, with the hybrid biomaterials fitting better to bone tissue engineering applications due to their similar compositions to natural bones [13,14]. For example, biodegradable polymers such as poly(L-lactic acid) (PLLA) (L-lactic acid isomer of polylactic acid (PLA), an aliphatic thermoplastic polyester obtained by polymerizing lactide monomers) have been used for scaffold design doped with dicalcium silicate (C 2 S) nanoparticles as an ideal candidate for novel bone graft substitutes with enhanced mechanical and biodegradable properties, and biointeractive nature [15,16]. Scaffolds fabricated from (PLLA)/dicalcium phosphate dihydrate (DCPD) composite by indirect casting had also shown to effectively improve the mechanical strength and biocompatibility for the repair of bone defects when compared to the scaffold from neat PLLA [17]. From which the h...

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