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Riedl, Moritz ; Rupp, Markus ; Walter, Nike ; Henssler, Leopold ; Kerschbaum, Maximilian ; Popp, Daniel ; Vadalà, Gianluca ; Alt, Volker ; Docheva, Denitsa ; Pfeifer, Christian G.

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

Riedl, Moritz , Rupp, Markus , Walter, Nike , Henssler, Leopold , Kerschbaum, Maximilian , Popp, Daniel , Vadalà, Gianluca, Alt, Volker , Docheva, Denitsa and Pfeifer, Christian G. (2022) Practical Relevance of Institutional Guidelines in Translational Large Animal Studies of Cartilage Repair—A Multidisciplinary Survey. Medicina 58 (12), p. 1834.

Date of publication of this fulltext: 23 Dec 2022 07:44
Article
DOI to cite this document: 10.5283/epub.53457


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 ...

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.



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Details

Item typeArticle
Journal or Publication TitleMedicina
Publisher:MDPI
Place of Publication:BASEL
Volume:58
Number of Issue or Book Chapter:12
Page Range:p. 1834
Date13 December 2022
InstitutionsMedicine > Lehrstuhl für Unfallchirurgie
Identification Number
ValueType
10.3390/medicina58121834DOI
KeywordsDEFECTS; KNEE; JOINT; cartilage repair; translational study; survey; guidelines; animal model
Dewey Decimal Classification600 Technology > 610 Medical sciences Medicine
StatusPublished
RefereedYes, this version has been refereed
Created at the University of RegensburgYes
URN of the UB Regensburgurn:nbn:de:bvb:355-epub-534575
Item ID53457

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