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-InjectTM, (2) signs of cartilage tissue (p = 0.003), more pronounced in BoneReg-InjectTM, and (3) signs of fibrous tissue (p < 0.001), less pronounced in BoneReg-InjectTM. 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.
Highlights
Introduction published maps and institutional affilWhenever disease or trauma causes skeletal void or when healing of a fracture is impaired, a common surgical technique is to harvest bone from the iliac crest of the patient and insert it to the injury site to fill the void
The aim of the study was to compare the performance of BoneReg-InjectTM and chronOS Inject® in a sheep tibia model with respect to new bone formation, calcification and effect on surrounding tissues on the basis of findings from X-ray micro-computed tomography (CT) combined with histology after an observation period of weeks, and to study the long-term effect of the BoneReg-InjectTM implant in a similar model with an observation period of months
3 months in vivo, the mineral phase volume of chronOS Inject® was reduced to 5 shows a seriesphase of images selected from two animals eachtogroup rep29.6 Figure mm while the mineral volume of BoneReg-InjectTM
Summary
Introduction published maps and institutional affilWhenever disease or trauma causes skeletal void or when healing of a fracture is impaired, a common surgical technique is to harvest bone from the iliac crest of the patient and insert it to the injury site to fill the void (autograft). Autografts are regarded as the golden standard in orthopedic surgery. Still, this procedure has a severe drawback, i.e., donor site morbidity such as pain and numbness [1]. Several new products have been introduced, intended to replace bone autografts for filling of skeletal voids and/or for stimulation of bone healing [2,3]. This rapidly growing group of materials is commonly referred to as “synthetic bone graft substitutes”. Two major groups of synthetic bone graft materials can be identified where one group has properties intended to provide bone induction, while in iations
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