ObjectiveThe goal of this review was to determine whether calcium silicate (wollastonite) as a bone graft material is a viable alternative to autogenous bone or whether the evidence base for its use is weak.MethodsIn this systematic review, electronic databases (MEDLINE/PubMed and BVS) were searched for relevant articles in indexed journals. Articles published in a 10-year period were identified (n = 48). After initial selection, 17 articles were assessed for eligibility; subsequently, seven articles were excluded and 10 articles were included.ResultsAmong the studies included, 20% emphasized the importance of randomization, which adds reliability to the study, minimizing the risk of bias. High variability was observed in the material used, such as additives, amounts, dosage, and chemical alterations, rendering direct comparison among these studies impossible. The experimental periods varied considerably; one of the studies did not include statistical analysis, weakening the evaluation. Nonetheless, the true potential of wollastonite as a graft material conducive to new bone formation was reported in all studies.ConclusionThe results support the use of wollastonite as a bone graft material. The initial research question was answered despite the significant variability observed among these preclinical studies, which hindered the precision of this analysis.
Wollastonite-poly(n-butyl-2-cyanoacrylate) composite (W-BCA) has been proposed to immobilize anatomically bone fragments in order to achieve an optimal healing process. The present study evaluated the in vitro and in vivo behavior of three types of fillers: powdered natural wollastonite (Wn), synthetic pseudowollastonite powder (Ws), and synthetic pseudowollastonite powder coated with 5% acetyl tributyl citrate (Wst). The Wst-BCA composite underwent a higher degradability in the real-time degradation test and a superior cytotoxic effect; whereas the Wn-BCA composite showed a higher degradability in the accelerated test with no cytotoxicity. The formation of an extracellular collagenous matrix deposit on its surface and the most favorable new bone formation on Wn-BCA indicate its potential for bone adhesive use in unstable orthopedic traumas.
Abstract-Medical device regulatory agencies have adopted quality and risk management approaches to demonstrate compliance with the essential principles of safety and performance. For this reason, specific standards are established in the medical device sector for the quality management system by regulatory purposes and a systematic process, in order to minimize risks throughout the life-cycle of the product. The objectives of this paper are to show how the risk management process can be inserted into the product design/development strategy within a quality management system and to apply such strategy to an osseous adhesive as a case study. Integration of a risk management system within a QMS can be an advantage for manufacturers of medical devices in order to comply with regulatory requirements. At the design and development stages the risk management principles should be applied and used to identify and address safety issues and to plan risk control activities. The risk assessment conducted shows that the Wollastonite / n-butyl-2-cyanoacrylate adhesive composite is safe by design. Adequate labeling and operating instructions have to be incorporated to the final product to minimize the risks or improper usage and storage outside prescribed environmental conditions. In addition, validation and control measures of the sterilization process and packaging have to be taken to maintain the acceptable levels for all identified risks.
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