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

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 1-7cm², without severe knee OA (Kellgren-Lawrence grade 0-3).