Biological Response to a Novel Hybrid Polyoligomer: in vitro and in vivo Models.

The aim of the study is to evaluate biocompatibility of a novel hybrid polyoligomer in in vitro and in vivo models. MATERIALS AND METHODS: Cytotoxicity of the material was investigated using the MTT assay with human dermal fibroblasts as test cultures. To study direct interaction of the hybrid polyoligomer with cells, the fibroblasts were cultured on the polymer samples for 96 h, the cultures were assessed every 24 h using fluorescence microscopy. To study the tissue reaction in the area of contact with the donor bed and the morphological features of the implanted sample restructuring, a case-control study was performed using a rabbit model. Samples of hybrid polyoligomer were implanted into the bone defect formed in the left iliac crest in 10 rabbits. In the control group, the prepared allograft samples were transplanted into similar defects in 10 animals. The rabbits were sacrificed 4 and 8 weeks after the operation. The standard morphological methods with hematoxylin and eosin staining and immunohistochemical Ki-67 proliferation marker evaluation were used to assess the state of tissues in the defect area. RESULTS: The results demonstrate that the hybrid polyoligomer is not cytotoxic (cytotoxicity score 0-1), cells adhere well to its surface, retain their viability and typical morphology throughout the entire observation period. No negative impact of material implantation on the health state and behavior of animals was detected. Morphological examination showed the absence of inflammatory changes, formation of thin-walled capillary vessels, and considerable proliferative activity of mesenchymal cells in the defect area, even though it was more intense than in the control group. CONCLUSION: No inflammation signs were detected by 8th week of the experiment. It was defined that new bone was beginning to form. The results of analysis support the conclusion that the developed hybrid materials are prospective for further research as potential bone substitute.

Augmentation of Pedicle Screws Using Bone Grafting in Patients with Spinal Osteoporosis.

The aim of the study was to develop a new method of vertebral augmentation based on autologous and allogeneic bone chips to be used in pedicle screw fixation and to compare this method with the technique based on polymethyl methacrylate (PMMA). Materials and Methods: This prospective non-randomized study included 164 patients with degenerative pathologies or traumatic injuries of the lumbar spine and transitional thoracolumbar segments; 153 of the operated patients were followed up for 18 months. In these patients, radiodensity of the cancellous bone tissue was below 110 HU by the Hounsfield scale. Patients with degenerative spinal disorders underwent pedicle screw fixation using transforaminal interbody fusion; patients with traumatic spinal injuries underwent intermediate pedicle screw fixation, and those with a loss of vertebral body height by >50% underwent anterior fusion.The patients were divided into three groups: in group 1 (n=39), bone tissue augmentation was performed using PMMA; in group 2 (n=21), augmentation was done with bone chips; in group 3 (n=93), no augmentation was performed (control group). The follow-up period was 12 months; cases with fixator breakage or loosening were recorded. Results: After augmentation with PMMA, 11 cases (28.2%) of fixator destabilization were detected. With bone chips, fixator instability developed in 2 patients (9.5%) only, whereas in patients operated without augmentation, the instability was observed in 43 cases (46.2%). With PMMA augmentation, the incidence rate of fixator destabilization did not significantly differ from that in the control group (p=0.0801), while the use of bone chips resulted in a statistically significant decrease of this index compared to the control group (p=0.0023). A logistic regression analysis confirmed the superiority of the developed method over the PMMA-based vertebral augmentation. Conclusion: The use of bone chips for vertebral augmentation provides a statistically significant decrease in the incidence of pedicle screw fixator destabilization in the post-operative period. By reducing the risk of proximal loosening and eliminating the risk of bone cement drainage into the spinal canal and vascular bed, the proposed method may become especially effective in patients with impaired bone density.