Mineralization in a Critical Size Bone-Gap in Sheep Tibia Improved by a Chitosan-Calcium Phosphate-Based Composite as Compared to Predicate Device

Materials

Halldór Jónsson¹  Sigurbergur Kárason¹  Atli Dagbjartsson¹  Elín H. Laxdal¹  Jóhannes Gíslason²  Jón M. Einarsson²  Chuen-How Ng²  Gissur Örlygsson³  Eggert Gunnarsson⁴ 

[1] Faculty of Medicine, University of Iceland, 101 Reykjavík, Iceland;Genis hf., 580 Siglufjörður, Iceland;IceTec, 112 Reykjavík, Iceland;Institute for Experimental Pathology, University of Iceland, 112 Reykjavík, Iceland;

关键词: bone implant;    bone defects;    chitosan;    degree of deacetylation;    bone formation;    X-ray micro CT;   

DOI  :  10.3390/ma15030838

来源: DOAJ

【 摘 要 】

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 (p < 0.001), higher in BoneReg-Inject^TM, (2) signs of cartilage tissue (p = 0.003), more pronounced in BoneReg-Inject^TM, and (3) signs of fibrous tissue (p < 0.001), less pronounced in BoneReg-Inject^TM. Mineral content at 13 months postoperative was significantly higher than at 12 weeks (p < 0.001 and p < 0.05, for implant core and rim, respectively). The data demonstrate the potential of deacetylated chitin derivatives to stimulate bone formation.

【 授权许可】

Unknown