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Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study

The purpose of this study was to assess the safety and efficacy of chitosan–platelet-rich plasma (PRP) hybrid implants used as an adjunct to surgical rotator cuff repair in a pivotal Good Laboratory Practice (GLP)-compliant study. The infraspinatus tendon was transected in 48 skeletally mature ewes...

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Autores principales: Chevrier, Anik, Hurtig, Mark B., Lavertu, Marc
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8622568/
https://www.ncbi.nlm.nih.gov/pubmed/34834370
http://dx.doi.org/10.3390/pharmaceutics13111955
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author Chevrier, Anik
Hurtig, Mark B.
Lavertu, Marc
author_facet Chevrier, Anik
Hurtig, Mark B.
Lavertu, Marc
author_sort Chevrier, Anik
collection PubMed
description The purpose of this study was to assess the safety and efficacy of chitosan–platelet-rich plasma (PRP) hybrid implants used as an adjunct to surgical rotator cuff repair in a pivotal Good Laboratory Practice (GLP)-compliant study. The infraspinatus tendon was transected in 48 skeletally mature ewes and repaired with a transosseous-equivalent (TOE) technique. In the two treatment groups, a chitosan–PRP solution was injected at the footprint between the tendon and the bone and on top of the repaired site (2 mL or 3 mL doses, n = 12 per group). To further assess chitosan safety, a chitosan–water solution was injected at the same sites (3 mL, n = 12). Outcome measures included Magnetic Resonance Imaging (MRI) assessment and clinical pathology at 3 months and 6 months and histopathology at 6 months. The tendon gap was decreased at 3 months on MRI images and certain histopathological features were improved at 6 months by chitosan–PRP treatment compared to controls. The group treated with chitosan–water was not different from controls. Chitosan–PRP treatment induced no negative effects in the sheep, which suggests high safety. This study provides further evidence on the safety and efficacy of chitosan–PRP for rotator cuff repair augmentation, which could eventually be used in a clinical setting.
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spelling pubmed-86225682021-11-27 Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study Chevrier, Anik Hurtig, Mark B. Lavertu, Marc Pharmaceutics Article The purpose of this study was to assess the safety and efficacy of chitosan–platelet-rich plasma (PRP) hybrid implants used as an adjunct to surgical rotator cuff repair in a pivotal Good Laboratory Practice (GLP)-compliant study. The infraspinatus tendon was transected in 48 skeletally mature ewes and repaired with a transosseous-equivalent (TOE) technique. In the two treatment groups, a chitosan–PRP solution was injected at the footprint between the tendon and the bone and on top of the repaired site (2 mL or 3 mL doses, n = 12 per group). To further assess chitosan safety, a chitosan–water solution was injected at the same sites (3 mL, n = 12). Outcome measures included Magnetic Resonance Imaging (MRI) assessment and clinical pathology at 3 months and 6 months and histopathology at 6 months. The tendon gap was decreased at 3 months on MRI images and certain histopathological features were improved at 6 months by chitosan–PRP treatment compared to controls. The group treated with chitosan–water was not different from controls. Chitosan–PRP treatment induced no negative effects in the sheep, which suggests high safety. This study provides further evidence on the safety and efficacy of chitosan–PRP for rotator cuff repair augmentation, which could eventually be used in a clinical setting. MDPI 2021-11-18 /pmc/articles/PMC8622568/ /pubmed/34834370 http://dx.doi.org/10.3390/pharmaceutics13111955 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Chevrier, Anik
Hurtig, Mark B.
Lavertu, Marc
Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study
title Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study
title_full Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study
title_fullStr Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study
title_full_unstemmed Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study
title_short Chitosan–Platelet-Rich Plasma Implants Improve Rotator Cuff Repair in a Large Animal Model: Pivotal Study
title_sort chitosan–platelet-rich plasma implants improve rotator cuff repair in a large animal model: pivotal study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8622568/
https://www.ncbi.nlm.nih.gov/pubmed/34834370
http://dx.doi.org/10.3390/pharmaceutics13111955
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