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新型解剖形状聚碳酸酯聚氨酯全半月板假体的体内性能:在山羊身上进行的12个月评估

In Vivo Performance of a Novel, Anatomically Shaped, Total Meniscal Prosthesis Made of Polycarbonate Urethane: A 12-Month Evaluation in Goats.

作者信息

Vrancken Anne C T, Hannink Gerjon, Madej Wojciech, Verdonschot Nico, van Tienen Tony G, Buma Pieter

机构信息

Department of Orthopaedics, Radboud University Medical Center, Nijmegen, the Netherlands.

Laboratory of Biomechanical Engineering, University of Twente, Enschede, the Netherlands.

出版信息

Am J Sports Med. 2017 Oct;45(12):2824-2834. doi: 10.1177/0363546517713687. Epub 2017 Jul 18.

DOI:10.1177/0363546517713687
PMID:28719787
Abstract

BACKGROUND

Injury or loss of the meniscus generally leads to degenerative osteoarthritic changes in the knee joint. However, the treatment options for symptomatic patients with total meniscectomy are limited. Therefore, we developed a novel, anatomically shaped, total meniscal implant made of polycarbonate urethane.

PURPOSE

To evaluate the in vivo performance of this novel total meniscal implant. The assessment particularly focused on the implant's response to long-term physiological loading in a goat model and its chondroprotective capacity in comparison to clinically relevant controls.

STUDY DESIGN

Controlled laboratory study.

METHODS

Surgery was performed to the stifle joint of 26 female Saanen goats, subdivided into 4 groups: implant, allograft, total meniscectomy, and sham surgery. The sham group's contralateral joints served as nonoperated controls. After 12 months of follow-up, investigators evaluated implant wear, deformation, and the histopathological condition of the synovium and cartilage.

RESULTS

Wear of the implant's articulating surfaces was minimal, which was confirmed by the absence of wear particles in the synovial fluid. Implant deformation was limited. However, one implant failed by complete tearing of the posterior horn extension. No differences in cartilage histopathological condition were observed for the implant, allograft, and meniscectomy groups. However, locally, the cartilage scores for these groups were significantly worse than those of the nonoperated controls.

CONCLUSION

Whereas this study demonstrated that the novel implant is resistant to wear and that deformation after 12 months of physiological loading is acceptable, reinforcement of the implant horns is necessary to prevent horn failure. Although the implant could not protect the cartilage from developing degenerative changes, the progression of damage was similar in the allograft group.

CLINICAL RELEVANCE

This novel polycarbonate urethane implant may have the potential to become an alternative treatment for symptomatic patients with total meniscectomy.

摘要

背景

半月板损伤或缺失通常会导致膝关节发生退行性骨关节炎改变。然而,对于接受全半月板切除术的有症状患者,治疗选择有限。因此,我们开发了一种新型的、符合解剖形状的、由聚碳酸酯聚氨酯制成的全半月板植入物。

目的

评估这种新型全半月板植入物的体内性能。评估特别关注该植入物在山羊模型中对长期生理负荷的反应及其与临床相关对照相比的软骨保护能力。

研究设计

对照实验室研究。

方法

对26只雌性萨能山羊的 stifle 关节进行手术,分为4组:植入物组、同种异体移植组、全半月板切除组和假手术组。假手术组的对侧关节作为未手术对照。随访12个月后,研究人员评估植入物的磨损、变形以及滑膜和软骨的组织病理学状况。

结果

植入物关节面的磨损极小,这通过滑液中无磨损颗粒得到证实。植入物变形有限。然而,有一个植入物因后角延伸部完全撕裂而失效。在植入物组、同种异体移植组和半月板切除组中,未观察到软骨组织病理学状况的差异。然而,局部而言,这些组的软骨评分明显低于未手术对照。

结论

尽管本研究表明新型植入物耐磨,且在生理负荷12个月后的变形可接受,但有必要加强植入物的角部以防止角部失效。虽然该植入物不能保护软骨免于发生退行性改变,但同种异体移植组的损伤进展与之相似。

临床意义

这种新型聚碳酸酯聚氨酯植入物可能有潜力成为全半月板切除术有症状患者的替代治疗方法。

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