Preclinical Evaluation of Biomaterials and Medical Devices for the Musculoskeletal System

A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Biomedical Engineering and Biomaterials".

Deadline for manuscript submissions: 15 June 2025 | Viewed by 2134

Special Issue Editors


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Guest Editor
Surgical Sciences and Technologies, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
Interests: orthopaedics; biocompatibility; preclinical research; medical devices; tissue engineering

E-Mail Website
Guest Editor
Surgical Sciences and Technologies, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
Interests: biomaterials; musculo-skeletal pathologies; in vitro and in vivo research; biological and biophysical therapies

Special Issue Information

Dear Colleagues,

In the orthopaedic field, the advancement of biomedical technology and the use of implant biomaterials for prosthetic surgery, implantology and osteosynthesis have resulted in great developments for patients, improving their quality of life, relieving pain, and allowing for healthy and better ageing. In recent years, technological innovation led and still leads to the exponential development of novel biomaterials and sophisticated medical devices, including nanomaterials, smart implantable devices, functionalized implant biomaterials and coatings, and controlled drug delivery technologies. These advances hold the promise of significant therapeutic benefits, but also introduce new complexities and potential risks. Consequently, it is imperative that preclinical evaluations are conducted with the utmost detail and rigor to demonstrate and guarantee the safety and efficacy of these novel products; extensive testing for biocompatibility, safety, and functional performance is required to identify any issues prior to clinical trials and large-scale deployment. This approach protects patient health and ensures that only the safest and most reliable and innovative medical devices reach the market.

Taking into account that the development of a new biocompatible material is a “multidisciplinary” approach, this Special Issue of Bioengineering entitled “Preclinical Evaluation of Biomaterials and Medical Devices for the Musculoskeletal System” encourages the submission of original basic, translational research and review articles focused on, but not limited to, in silico, in vitro and/or in vivo preclinical tests necessary to establish the safety, feasibility, biocompatibility and efficacy of innovative biomaterials and medical devices for orthopaedic applications. Moreover, we also encourage the submission of works on methods/techniques that may support the traditional regulatory steps for the evaluation of new biomaterials and medical devices, including the following examples:

- Physical–chemical properties of biomaterials;

- Functional performance of medical devices;

- Innovations and new technologies adopted to create new and more accurate preclinical models;

- Computational in silico models;

- Omic analyses;

- Advanced imaging techniques.

Dr. Silvia Brogini
Dr. Matilde Tschon
Guest Editors

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Keywords

  • biomaterials and medical devices
  • preclinical testing
  • humanized advanced in vitro models
  • orthopaedic applications

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Published Papers (1 paper)

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25 pages, 1504 KiB  
Systematic Review
Scaffolds for Osteochondral Lesions of the Talus: Systematic Review and Meta-Analysis of the Last Ten Years Literature
by Francesca Veronesi, Simone Ottavio Zielli, Silvia Brogini, Elena Artioli, Alberto Arceri, Antonio Mazzotti, Cesare Faldini and Gianluca Giavaresi
Bioengineering 2024, 11(10), 970; https://doi.org/10.3390/bioengineering11100970 - 27 Sep 2024
Cited by 1 | Viewed by 1706
Abstract
Scaffolds are widely used devices for the treatment of osteochondral lesions of the talus (OCLT), aimed at enhancing mechanical stability and fostering chondrogenic differentiation. A systematic review and meta-analysis were performed to evaluate the safety, and clinical and radiological results of scaffolds for [...] Read more.
Scaffolds are widely used devices for the treatment of osteochondral lesions of the talus (OCLT), aimed at enhancing mechanical stability and fostering chondrogenic differentiation. A systematic review and meta-analysis were performed to evaluate the safety, and clinical and radiological results of scaffolds for OCLT management. On 2 January 2024, a search was performed in four databases (PubMed, Embase, Web of Science, and Scopus), according to PRISMA guidelines. The risk of bias in the included studies was also evaluated. Thirty clinical studies were included in the qualitative analysis: 12 retrospective case series, 3 retrospective comparative studies, 9 prospective case series, 1 prospective comparative study, and 1 Randomized Controlled Trial (RCT). Natural scaffolds, such as bilayer collagen (COLL)I/III and hyaluronic scaffolds, were the most employed. Only minor adverse events were observed, even if more serious complications were shown, especially after medial malleolar osteotomy. An overall clinical and radiological improvement was observed after a mean of 36.3 months of follow-up. Patient age and Body Mass Index (BMI), lesion size, and location were correlated with the clinical outcomes, while meta-analysis revealed significant improvement in clinical scores with hyaluronic scaffolds compared to microfracture alone. This study highlights the safety and positive clinical outcomes associated with the use of scaffolds for OCLT. In the few available comparative studies, scaffolds have also demonstrated superior clinical outcomes compared to microfractures alone. Nevertheless, the analysis has shown the limitations of the current literature, characterized by an overall low quality and scarcity of RCTs. Full article
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