Department of Orthopaedic Surgery, Research School CAPHRI, Maastricht University Medical Center, Maastricht, the Netherlands.
DSM Biomedical BV, Geleen, the Netherlands.
J Biomed Mater Res B Appl Biomater. 2018 Feb;106(2):771-779. doi: 10.1002/jbm.b.33886. Epub 2017 Mar 27.
Polymeric sublaminar cables have a number of advantages over metal cables in the field of spinal deformity surgery, with decreased risk of neurological injury and potential for higher correction forces as the two most predominant. However, currently available polymer cables are radiolucent, precluding postoperative radiological assessment of instrumentation stability and integrity. This study provides a preclinical assessment of a woven UHMWPE cable made with radiopaque UHMWPE fibers. Our primary goal was to determine if the addition of a radiopacifier negatively affects the mechanical properties of UHMWPE woven cables. Tensile mechanical properties were determined and compared to suitable controls. Radiopacity was evaluated and radiopacifier leaching was assessed in vitro and in vivo. Finally, in vivo bismuth organ content was quantified after a 24-week implantation period in sheep. Results show that the mechanical properties of woven UHMWPE cables were not deleteriously affected by the addition of homogenously dispersed bismuth oxide particles within each fiber. Limited amounts of bismuth oxide were released in vitro, well below the toxicological threshold. Tissue concentrations lower than generally accepted therapeutic dosages for use against gastrointestinal disorders, well below toxic levels, were discovered in vivo. These results substantiate controlled clinical introduction of these radiopaque UHMWPE cables. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 771-779, 2018.
聚合物亚层电缆在脊柱畸形手术领域相对于金属电缆具有许多优势，其中两个最主要的优势是降低了神经损伤的风险和更高的矫正力潜力。然而，目前可用的聚合物电缆是不透射线的，这使得术后无法对器械的稳定性和完整性进行放射学评估。本研究对一种用放射性 UHMWPE 纤维制成的编织 UHMWPE 电缆进行了临床前评估。我们的主要目标是确定添加不透射线剂是否会对 UHMWPE 编织电缆的机械性能产生负面影响。我们测定了拉伸机械性能并与合适的对照进行了比较。评估了射线可透性，并在体外和体内评估了射线不透剂的浸出。最后，在绵羊体内植入 24 周后定量了体内铋器官含量。结果表明，编织 UHMWPE 电缆的机械性能不会因每根纤维中均匀分散的氧化铋颗粒的添加而受到不利影响。体外释放的氧化铋数量有限，远低于毒性阈值。在体内发现的组织浓度低于一般用于治疗胃肠道疾病的治疗剂量，远低于毒性水平。这些结果证实了这些放射性 UHMWPE 电缆的受控临床引入。©2017 威利父子公司。生物医学材料研究杂志 B：应用生物材料，106B：771-779，2018。
