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

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


Title: Mineralization in a Critical Size Bone-Gap in Sheep Tibia Improved by a Chitosan-Calcium Phosphate-Based Composite as Compared to Predicate Device
Author: Örlygsson, Gissur
Laxdal, Elín H.
Kárason, Sigurbergur
Dagbjartsson, Atli
Gunnarsson, Eggert
Ng, Chuen How
Einarsson, Jón M.
Gíslason, Jóhannes
Jónsson, Halldór
Date: 2022-02-01
Language: English
Scope:
University/Institute: Landspitali - The National University Hospital of Iceland
Department: Cardio-Vascular Center
Faculty of Medicine
Office of Division of Clinical Services II
Perioperative Services
Surgical Services
Series: Materials; 15(3)
ISSN: 1996-1944
DOI: https://doi.org/10.3390/ma15030838
Subject: Æðaskurðlækningar; Æðaskurðlæknisfræði; Svæfinga- og gjörgæslulæknisfræði; Bæklunarskurðlæknisfræði; Bone defects; Bone formation; Bone implant; Chitosan; Degree of deacetylation; Histology; Sheep tibia; X-ray micro CT; Materials Science (all); Condensed Matter Physics
URI: https://hdl.handle.net/20.500.11815/3157

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Citation:

Örlygsson , G , Laxdal , E H , Kárason , S , Dagbjartsson , A , Gunnarsson , E , Ng , C H , Einarsson , J M , Gíslason , J & Jónsson , H 2022 , ' Mineralization in a Critical Size Bone-Gap in Sheep Tibia Improved by a Chitosan-Calcium Phosphate-Based Composite as Compared to Predicate Device ' , Materials , vol. 15 , no. 3 , 838 . https://doi.org/10.3390/ma15030838

Abstract:

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™, (2) signs of cartilage tissue (p = 0.003), more pronounced in BoneReg-Inject™, and (3) signs of fibrous tissue (p < 0.001), less pronounced in BoneReg-Inject™. 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.

Description:

Funding Information: Funding: This work was supported by the Technology Development Fund, managed by the Icelandic Centre for Research [RAN 090303-0246]. Publisher Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

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