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PURPOSE
Patient-specific instruments (PSIs) are helpful tools in high tibial osteotomy (HTO) in patients with symptomatic varus malalignment of the mechanical leg axis. However, the precision of HTO can decrease with malpositioned PSI. This study investigates the influence of malpositioned PSI on axis correction, osteotomy, and implant placement.

METHODS
With a mean three-dimensional (3D) model (0.8° varus), PSI-navigated HTOs were computer simulated. Two different guide designs, one with stabilising hooks and one without, were used. By adding rotational and translational offsets of different degrees, wrong placements of PSI were simulated. After 5° valgisation of the postoperative mechanical axis, the distance between joint-plane and osteotomy screws, respectively, were measured. The same simulations were performed in a patient with varus deformity (7.4° varus).

RESULTS
In the mean 3D model, the postoperative mechanical axis was within 3.9°-4.5° valgus with mean value of 4.1° ± 0.1° (correct axis 4.2° valgus). Surgical failure concerning osteotomy occurred in 17 of 76 HTOs. Significantly safer screw placement was observed using PSI with stabilising hooks (p = 0.012). In the case of the 3D model with 7.4° varus deformity, the postoperative mechanical axis was within 3.2°-3.9° valgus with mean value of 3.8° ± 0.2° (correct axis 3.9° valgus). Surgical failure concerning osteotomy occurred in 3 of 38 HTOs. Screws were always within the safety distance.

CONCLUSION
The clinical relevance of the presented study is that malpositioning of a PSI within the possible degrees of freedom does not have a relevant influence on the axis correction. The most vulnerable plane for surgical failure is the sagittal plane, wherefore the treating surgeon should verify correct guide placement to prevent surgical failure, particularly in this plane.

LEVEL OF EVIDENCE
III.