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A novel approach for opening-wedge high tibial osteotomy (OWHTO) with patient-specific instrumentation (PSI) was evaluated for its safety, feasibility, and accuracy. Next, the mechanical medial proximal tibial angle (mMPTA) was assessed as a potential planning angle by investigating the relation with the mechanical femorotibial angle (mFTA). Ten OWHTO cases were 3D planned using the mMPTA and operated with a customized 3D-printed wedge and cast which resembled the intended osteotomy opening. Patients were closely monitored for intraoperative and postoperative complications up to 1 year after surgery. Radiological assessment was conducted on full leg standing radiographs and supine lower limb computed tomography-scans preoperatively and 3 months after surgery. No intraoperative complications or logistical issues during PSI processing were observed. Absolute accuracy outcomes showed a correction error of 1.3° ± 1.1 mMPTA and 0.9° ± 0.6 mFTA with all osteotomies falling in (−2°; + 2°) mFTA around the target. The mMPTA and mFTA were found to have a strong correlation in both 3D (r = 0.842, p = 0.002) and 2D (r = 0.766, p = 0.01) imaging for effective correction. The study confirmed the development of a safe and feasible PSI technique in OWHTO with excellent accuracy outcomes. The strong correlation between the mMPTA and mFTA indicated that soft tissue changes after OWHTO are of minor significance to the final alignment in ligament-stable patients. Finally, the mMPTA was found to be a reliable planning angle in 3D software for obtaining the intended lower limb realignment and its use can therefore be recommended in modern OWHTO planning.

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