Personalised opening wedge high tibial osteotomy with patient-specific plates and instrumentation accurately controls coronal correction and posterior slope: Results from a prospective first case series

Background: Patient specific devices represent a promising tool to improve accuracy and simplify high tibial osteotomy (HTO) procedures. The current study aims to assess accuracy of the correction of alignment and posterior tibial slope (PTS), and provide patient reported outcomes (PROMs) of a new personalised cutting guide and fixation plate (TOKA) system for HTO in patients with medial osteoarthritis (OA) and varus knee. Methods: 25 patients (mean age 54.4 years) with medial OA and varus knee malalignment who underwent HTO with the TOKA system were prospectively evaluated pre-operatively, 1, 3, 6 and 12-months follow-up. Standing long-leg and lateral radiographs of the knee were used to assess the hip-knee-ankle (HKA) angle and the PTS, respectively. Accuracy was defined as the difference in planned minus achieved correction. The patient reported outcomes collected were the KOOS score, EQ5D, KSS score, and VAS pain scores. All statistical analyses were performed using IBM SPSS Statistics for Windows. Results: The mean preoperative HKA was 170.7° (SD ± 3.2°); the mean postoperative HKA was 177.4° (SD ± 2.9°). The overall mean difference between planned and achieved correction in terms of HKA was 2.1° (SD ± 2.0°). The mean difference between planned and achieved PTS was 0.2° (SD ± 0.4°). All the assessed PROMs had a significant (p < 0.001) increase from the pre-operative value to postoperative evaluation and showed a significant (p < 0.001) improvement with follow-up time. Conclusions: TOKA personalised HTO system showed accurate correction in terms of both coronal and sagittal alignment, and excellent patient reported outcomes. Level of evidence: 4, prospective case series. Registration in public trial registry: registered at ClinicalTrial.gov [NCT04574570].