Limited Osteochondral Repair by a Biomimetic Collagen Scaffold - One to Three Years Clinical and Radiological Follow-Up Bjørn B Christensen1, CB Foldager1, NC Jensen2, M Lind3 1 Orthopedic Research Laboratory, Nørrebrogade 44, bygn. 1A, 1. Sal, Aarhus University Hospital, Denmark, bjornbc@gmail.com, tlf.: 22449180 2 Department of Orthopedic Surgery, Aarhus University Hospital, Denmark, 3 Division of Sports trauma, Aarhus University Hospital, Denmark Background Osteochondral injuries are therapeutically challenging and no gold standard treatment has been established. Cell-free, layered scaffolds are a new treatment option for these defects. The aim of this study was to evaluate the osteochondral repair in patients treated with The MaioRegen® scaffold, a cell-free biomimetic scaffold, consisting of type I collagen and hydroxyapatite. The scaffold has previously been shown to induce clinical subchondral bone and articular cartilage regeneration. Methods Eleven patients with osteochondral defects in the knee (n=7) or in the talus (n=4) were enrolled. All patients filled out clinical evaluation questionnaires preoperatively and at the final follow-up (2,5 years, range 1,9-3,1 years). The patients underwent preoperative MRI, and CT and MRI 1 (range 11,2 years) and 2,5 years postoperatively (range 1,9-3,1 years). The knee patients were evaluated using KOOS, IKDC and Tegner, while the ankle patients were evaluated using AOFAS Hindfoot and Tegners score. The cartilage and bone formation was evaluated using the MOCART score and semi-quantitatively, respectively. Results Three patients were re-operated and excluded due to treatment failure. CT: None of the patients had complete regeneration of the bone. 6/8 patients had no or very limited (<10%) bone formation in the defect. 1/8 had 20-30% bone filling and 1/8 had 40-50% bone filling. MRI: No improvement was found in the MOCART score at any time point. 5/6 patients experienced a clinical improvement while one patient experienced clinical worsening. The results were not significant. Conclusion Treatment of osteochondral defects in the ankle and knee joint with a multilayered collagen scaffold resulted in incomplete cartilage repair and limited subchondral bone repair at 1 and 2,5 year’s follow-up. Three patients were excluded due to treatment failure. This study raises concerns about the biological potential of the MaioRegen® implant for osteochondral repair and long-term studies are needed to investigate if the clinical improvements are permanent.