Application of 3D printed calcium phosphate cement scaffolds in open wedge high tibial osteotomy (owHTO) – A retrospective clinical evaluation

Calcium phosphate cements (CPC) are widely used materials for filling bone defects and bone augmentation. Developments in CPC formulations have led to a practically unlimited processability, allowing to use these formulations for new fabrication methods like extrusion-based 3D-printing. This study shows the application of INNOTERE 3D scaffolds, printed from a CPC paste and allowed to set, for open wedge high tibial osteotomy. It is the first time that a 3D-printed, certified medical device in this product class is used in a routine clinical application. The objective of this retrospective clinical evaluation is to assess the safety and clinical performance in regards to bone healing, osteointegration and resorption. In comparison to the also commercially available OSferion, a conventional, sintered ceramic, the 3D-printed scaffolds show no inferiority. This marks the first time that such a 3D-printed medical product is used in a broad evaluation regarding its clinical outcome.