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 (C3S), with the addition of C3S 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.
Highlights
Osteoporosis is a bone disease with the symptoms of chronic pain in the waist or back, or neck pain due to a compression fracture, significantly affecting the life quality of the elderly [1,2]
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. This double cement application with polymethyl methacrylate (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
poly(L-lactic acid) (PLLA)/C3 S composite membranes used in this study were prepared by the solvent casting technique, with tricalcium silicate powders synthesized by the sol-gel method [26] in our lab using Ca(NO3 )2 ·4H2 O
Summary
Osteoporosis is a bone disease with the symptoms of chronic pain in the waist or back, or neck pain due to a compression fracture, significantly affecting the life quality of the elderly [1,2]. Kyphoplasty is an effective surgical treatment for an immediate reduction of pain and deformity that can accompany vertebral compression fractures, in certain cases, defects or clefts in the vertebral body may cause the cement leakage into the epidural space, paraspinal soft tissues, or disc space [5,6] These cement materials, typically consisting of polymethyl methacrylate (PMMA) which offers mechanical stability, becomes a problem when the leakages of unreacted PMMA monomer liquid before cement polymerization in the bone bed occurred, which may cause remote organ embolism or local chemical or compress symptoms and even the thermal injury [7,8,9]. 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]
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