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Practical Relevance of Institutional Guidelines in Translational Large Animal Studies of Cartilage Repair—A Multidisciplinary Survey

Authors :
Moritz Riedl
Markus Rupp
Nike Walter
Leopold Henssler
Maximilian Kerschbaum
Daniel Popp
Gianluca Vadalà
Volker Alt
Denitsa Docheva
Christian G. Pfeifer
Source :
Medicina, Vol 58, Iss 12, p 1834 (2022)
Publication Year :
2022
Publisher :
MDPI AG, 2022.

Abstract

Background and Objective: Translational large animal models are inevitable to transfer cartilage repair methods into clinical practice. Guidelines for these trials have been published by guiding agencies (FDA, ASTM, EMEA) including recommendations for study descriptors and study outcomes. However, practical adherence to these recommendations is not achieved in all aspects. This study includes an assessment of the recommended aspects regarding practical relevance in large animal models for cartilage repair by professionals in the field. Materials and Methods: In an online based survey, 11 aspects regarding study design and 13 aspects regarding study outcome from previously published guidelines were evaluated (0–10 points, with 10 being most important) by study participants. Additionally, the survey contained questions related to professional experience (years), professional focus (preclinical, clinical, veterinarian, industry) and the preferred translational large animal model for cartilage repair. Results: The total number of survey participants was 37. Rated as most important for study design parameters was lesion size (9.54 pts., SD 0.80) followed by study duration (9.43 pts., SD 1.21); and method of scaffold fixation (9.08 pts., SD 1.30) as well as depth of the lesion (9.03 pts., SD 1.77). The most important aspects of study outcome were considered histology (9.41 pts., SD 0.86) and defect filling (8.97 pts., SD 1.21), while gene expression was judged as the least important (6.11 pts., SD 2.46) outcome. A total of 62.2% of all participants were researchers, 18.9% clinicians, 13.5% veterinarians and 5.4% industry employees. Conclusions: In translational research, recommendations published by guiding agencies receive broad theoretical consensus within the community, including both clinically and preclinically orientated scientists. However, implementation into practical research lacks in major aspects. Ongoing re-evaluation of the guidelines under involvement of all stakeholders and approaches to overcome financial and infrastructural limitations could support the acceptance of the guidance documents and contribute to standardization in the field.

Details

Language :
English
ISSN :
16489144 and 1010660X
Volume :
58
Issue :
12
Database :
Directory of Open Access Journals
Journal :
Medicina
Publication Type :
Academic Journal
Accession number :
edsdoj.0989cd112c714a0795212eeb5d7101fb
Document Type :
article
Full Text :
https://doi.org/10.3390/medicina58121834