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评价一种新型基于胶原的医疗器械(ElastiCo®)治疗急性跟腱损伤和预防腱周粘连的效果:体外生物相容性和体内研究。

Evaluation of a new collagen-based medical device (ElastiCo®) for the treatment of acute Achilles tendon injury and prevention of peritendinous adhesions: An in vitro biocompatibility and in vivo investigation.

机构信息

Laboratory of Preclinical and Surgical Studies, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Novagenit Srl, Trento, Italy.

出版信息

J Tissue Eng Regen Med. 2020 Aug;14(8):1113-1125. doi: 10.1002/term.3085. Epub 2020 Jul 13.

DOI:10.1002/term.3085
PMID:32592610
Abstract

Tendon healing still represents a challenge for clinicians because it is slow and incomplete. The most injured is the Achilles tendon, and surgery is the therapeutic strategy often adopted because it provides a quicker functional recovery. Peritendinous adhesions are the main complication of surgery with hyperplasia and chemotaxis of fibroblasts. A biomaterial that blocks fibroblast migration, without interfering with the passage of cytokines and growth factors, might be useful. The present study evaluated the biocompatibility of a new Type I collagen-based scaffold (ElastiCo®) and its ability to promote Achilles tendon healing, inhibiting adhesion formation. After verifying in vitro biocompatibility, physical, and mechanical properties of the scaffold, an in vivo study was performed in 28 rats, operated to induce an acute lesion in both Achilles tendons. One tendon was treated with the suture only and the contralateral one with suture wrapped with ElastiCo® film. After 8 and 16 weeks, it was observed that ElastiCo® reduced internal and external peritendinous adhesions and Collagen III content and increased Collagen I. Elastic modulus increased with both treatments over time. Current results highlighted the clinical translationality of ElastiCo® that could improve the quality of life in patients affected by Achilles tendon lesions surgically treated.

摘要

肌腱愈合仍然是临床医生面临的挑战,因为它的速度很慢,且不完整。受伤最严重的是跟腱,手术是经常采用的治疗策略,因为它可以更快地恢复功能。肌腱周围粘连是手术的主要并发症,其特征是成纤维细胞过度增生和趋化。一种能够阻止成纤维细胞迁移而不干扰细胞因子和生长因子通过的生物材料可能是有用的。本研究评估了一种新型基于 I 型胶原蛋白的支架(ElastiCo®)的生物相容性及其促进跟腱愈合、抑制粘连形成的能力。在体外验证了支架的生物相容性、物理和机械性能后,在 28 只大鼠中进行了体内研究,对双侧跟腱均进行急性损伤手术。一根肌腱仅用缝线处理,另一根肌腱用缝线包裹 ElastiCo®膜处理。8 周和 16 周后,观察到 ElastiCo®减少了内部和外部肌腱周围粘连以及 Collagen III 的含量,增加了 Collagen I。两种处理方法均随着时间的推移增加了弹性模量。目前的结果突出了 ElastiCo®的临床转化性,这可能会提高接受手术治疗的跟腱损伤患者的生活质量。

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