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新型创新手术程序——Agili C®的适应症、技术及结果进展报告

Report on Evolving Indications, Techniques, and Outcome of Novel and Innovative Surgical procedure - Agili C®.

作者信息

Kon Elizaveta, Conte Pietro, Anzillotti Giuseppe, Di Matteo Berardo, Verdonk Peter

机构信息

IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.

Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy.

出版信息

Curr Rev Musculoskelet Med. 2025 Apr;18(4):124-132. doi: 10.1007/s12178-025-09951-0. Epub 2025 Feb 14.

Abstract

BACKGROUND

Purpose of review Agili-C® (CartiHeal, Smith & Nephew) is an off-the-shelf aragonite-based (inorganic calcium carbonate) scaffold approved for clinical use in 2022 to treat chondral and osteochondral lesions eventually also in the context of mild to moderate knee osteoarthritis (Kellgren-Lawrence 0-3). The successful preclinical studies justified the subsequent clinical trials which reported both clinical and radiological significant improvements over time as well as superiority over standard surgical techniques for cartilage lesions treatment (i.e. microfractures/debridement). The aim of the present review is to summarize the available preclinical and clinical evidence and to report the current indications, surgical techniques and outcomes of this novel and innovative osteochondral scaffold.

RECENT FINDINGS

A total of six clinical reports, four single cohorts studies and a recent double arm randomized control trial followed by an analysis differentiating between femoral and trochlear lesions, have been published on Agili-C® safety and efficacy. Supported with an excellent safety profile, Agili-C® provided statistically significant clinical benefits at short and medium-term follow up in patients affected by knee joint surface lesions also when presenting in the context of mild to moderate knee osteoarthritis (Kellgren-Lawrence 0-3). Agili-C® (CartiHeal, Smith & Nephew) is an innovative aragonite-based osteochondral scaffold. It is an CE-marked and FDA approved off-the-shelf, cell-free, and cost-effective implant designed to treat knee joint surface lesions in the form of chondral and osteochondral defects. Its indications, supported by consistent clinical evidence, are single or multiple knee joint surface lesions (ICRS grade III or IV), with a total treatable area of 1-7cm, without severe knee OA (Kellgren-Lawrence grade 0-3).

摘要

背景

综述目的

Agili-C®(CartiHeal,施乐辉公司)是一种现成的基于文石(无机碳酸钙)的支架,于2022年获批用于临床治疗软骨和骨软骨损伤,最终也适用于轻度至中度膝关节骨关节炎(凯尔格伦-劳伦斯分级0-3级)的情况。成功的临床前研究为后续临床试验提供了依据,这些试验报告了随着时间推移临床和影像学上的显著改善,以及在软骨损伤治疗方面优于标准手术技术(即微骨折/清创术)。本综述的目的是总结现有的临床前和临床证据,并报告这种新型创新骨软骨支架的当前适应证、手术技术和结果。

最新发现

关于Agili-C®的安全性和有效性,共发表了六篇临床报告、四项单队列研究以及一项最近的双臂随机对照试验,随后进行了区分股骨和滑车损伤的分析。Agili-C®具有出色的安全性,在短期和中期随访中,对于膝关节表面损伤患者,即使是在轻度至中度膝关节骨关节炎(凯尔格伦-劳伦斯分级0-3级)的情况下,也提供了具有统计学意义的临床益处。Agili-C®(CartiHeal,施乐辉公司)是一种创新的基于文石的骨软骨支架。它是一种获得CE标志且经FDA批准的现成、无细胞且经济高效的植入物,旨在治疗软骨和骨软骨缺损形式的膝关节表面损伤。其适应证得到了一致临床证据的支持,为单处或多处膝关节表面损伤(国际软骨修复学会分级III或IV级),总可治疗面积为1-7平方厘米,无严重膝关节骨关节炎(凯尔格伦-劳伦斯分级0-3级)。

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