Complex Osteochondral Lesions of the Talus Treated With a Novel Bi-Phasic Aragonite-based Implant

To present initial results of a novel, bi-phasic, porous, biodegrade, and cell-free aragonite-based scaffold for treating complex osteochondral lesions the talus (OLT). Four subjects (2 males 2 females; 34-61 years old) were operated on their ankles due to chronic deep OLT-Hepple grades 4 or 5 (1.8-2.2 cm2). Three had OLT medial central trochlea, 1 combined lateral lesions. exposed through malleolus osteotomy, with an additional arthrotomy in Bi-phasic porous scaffolds (single implant implants) implanted press-fit manner using designated surgical toolset. Treatment outcome was followed clinically (Foot Ankle Outcome Score, EQ-5D 3L, Tegner activity scale) by medical imaging (radiographs, magnetic resonance imaging) from 18 32 months. All Foot Score values increased preoperative final follow-up (Symptoms 62 71, Pain 53 84, ADL 60 89, Sport 19 65, QoL 47). 3L 0.59 0.76, 1.5 3. Kellgren-Lawrence ankle radiographic scores remained stable 2). Postoperative MR evaluation demonstrated cartilage defect fill 75% 100% respect native 3 (4 OLTs), while lesion filled 25% 50%. No graft related serious adverse events failures reported. The use bi-phasic biodegradable treatment during reported period presented positive promising clinical radiologic outcome, without failures.