OA has been considered a contra-indication for cartilage regenerative procedures. The objective of this study is to present the outcome following implantation of an aragonite-based implant (Agili-C™, CartiHeal Ltd, Israel) for the treatment of chondral/osteochondral defects in subjects with or without knee osteoarthritis (OA).
251 subjects suffering from knee chondral/osteochondral defects, with different grades of concurrent knee OA (Kellgren Lawrence score 0-3), were treated in a large multicenter, randomized, controlled trial: 167 subjects received the aragonite-based implant, and 84 subjects were treated by debridement/microfracture (control group). Clinical evaluation was performed using the KOOS score at 6, 12, 18 and 24 months. Subjects were stratified according to the grade of joint degeneration: none or minimal OA (K/L 0-1) vs. mild or moderate OA (K/L2-3). Results were then compared to assess whether the OA grade had an impact on the clinical outcome and to identify difference in performance between the implant and control group.
In the implant group, 91 subjects had K/L 0-1, whereas 76 had K/L 2-3. At 6 months, the overall increase in KOOS score from baseline was 27.5 and 27.6 points respectively, well beyond the MCID. At the final 24 month follow-up, the increase was 43.9 points in K/L 0-1 and 41.9 points in K/L 2-3, without significant difference between these subgroups. Conversely, in the control group, the increase at 24 months was significantly lower: 23.2 points in K/L 0-1 subjects and 19 points in K/L 2-3 subjects. The scaffold group showed, therefore, superior outcome (p<0.0001), with a positive clinical trend throughout the entire study period.
The presence of mild-moderate OA did not impact the efficacy of the aragonite-based implant, which was able to provide significant clinical benefit even in patients with mild-moderate OA.