Method

Patient specific instruments (PSI) were developed to guide the surgeon during THA that were 3D printed with their bone models following a 3D software planning protocol (LPH software V2.5.1, Onefit-Medical, Eos Imaging Company, Besancon, France). Acetabular guides: cup, offset and straight reamer handle and impactor, femoral- and chisel guides were used in each THA (Fig. 1). To define anatomic bone landmarks and to generate a 3D model of each hip joint CT scans were performed preoperatively. The planning of component position was done by one surgeon (AZ) preop. Surgery was performed by two experienced surgeons (AZ, SD) on cadaver specimen with 4 hips in two separate series. A total of 8 hip replacements were evaluated pre- and postoperatively using CT-scans of each hip joint to compare planned to achieved results. Mechanical simulations of the guides were carried out to verify that there were no conflicts between the different instruments. To meet the ISO standard 16061: 2015 the compatibility of the instruments with the guides has been checked. Parameters were evaluated in 3D pelvic and femoral planes: center cup position, inclination angle, anteversion angle, cutting height and plan orientation, anteversion angle, flexion/extension angle, varus/valgus angle, anatomical and functional leg length, offset. Acceptance criteria: postop. parameters evaluated must not have a deviation of more than 5 degrees, 2,5 mm according to preop. planning. For every THA the test protocol has been completely realized.