Örlygsson Gissur, Laxdal Elín H, Kárason Sigurbergur, Dagbjartsson Atli, Gunnarsson Eggert, Ng Chuen-How, Einarsson Jón M, Gíslason Jóhannes, Jónsson Halldór
IceTec, 112 Reykjavík, Iceland.
Faculty of Medicine, University of Iceland, 101 Reykjavík, Iceland.
Materials (Basel). 2022 Jan 22;15(3):838. doi: 10.3390/ma15030838.
Deacetylated chitin derivatives have been widely studied for tissue engineering purposes. This study aimed to compare the efficacy of an injectable product containing a 50% deacetylated chitin derivative (BoneReg-Inject™) and an existing product (chronOS Inject) serving as a predicate device. A sheep model with a critical size drill hole in the tibial plateau was used. Holes of 8 mm diameter and 30 mm length were drilled bilaterally into the proximal area of the tibia and BoneReg-Inject™ or chronOS Inject were injected into the right leg holes. Comparison of resorption and bone formation in vivo was made by X-ray micro-CT and histological evaluation after a live phase of 12 weeks. Long-term effects of BoneReg-Inject™ were studied using a 13-month live period. Significant differences were observed in (1) amount of new bone within implant ( < 0.001), higher in BoneReg-Inject, (2) signs of cartilage tissue ( = 0.003), more pronounced in BoneReg-Inject, and (3) signs of fibrous tissue ( < 0.001), less pronounced in BoneReg-Inject. Mineral content at 13 months postoperative was significantly higher than at 12 weeks ( < 0.001 and < 0.05, for implant core and rim, respectively). The data demonstrate the potential of deacetylated chitin derivatives to stimulate bone formation.
脱乙酰几丁质衍生物已被广泛用于组织工程研究。本研究旨在比较一种含有50%脱乙酰几丁质衍生物的注射产品（BoneReg-Inject™）与作为对照器械的现有产品（chronOS Inject）的疗效。使用了一个在胫骨平台有临界尺寸钻孔的绵羊模型。在胫骨近端双侧钻直径8mm、长30mm的孔，并将BoneReg-Inject™或chronOS Inject注入右腿的孔中。在12周的存活期后，通过X射线显微CT和组织学评估对体内的吸收和骨形成进行比较。使用13个月的存活期研究了BoneReg-Inject™的长期效果。观察到以下显著差异：（1）植入物内新骨量（<0.001），在BoneReg-Inject中更高；（2）软骨组织迹象（=0.003），在BoneReg-Inject中更明显；（3）纤维组织迹象（<0.001），在BoneReg-Inject中不那么明显。术后13个月时的矿物质含量显著高于12周时（植入物核心和边缘分别为<0.001和<0.05）。数据表明脱乙酰几丁质衍生物具有刺激骨形成的潜力。
