The Efficiency and Cost‐Effectiveness of 3D ‐Printed Patient‐Specific Guide Plate for Patients Undergoing Open‐Wedge High Tibial Osteotomy: A Multicentered Randomized Controlled Trial

ABSTRACT Purpose Open‐wedge high tibial osteotomy (OWHTO) is established for young, active patients with medial knee osteoarthritis. Patient‐specific 3D‐printed guide plates have been introduced to improve surgical precision and efficiency, but evidence of clinical and economic benefit is limited. We aimed to determine whether a 3D‐printed patient‐specific guide plate improves efficiency, functional outcomes, and cost‐effectiveness compared to standard OWHTO. Methods In this multicenter randomized trial, patients scheduled for OWHTO were allocated to either conventional planning (control) or surgery using a patient‐specific 3D‐printed guide plate between November 2020 and June 2024. The primary endpoint was the 12‐month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Secondary outcomes included knee range of motion (flexion in degrees), 30‐s chair‐stand test (number of stands), operative time, and health economic measures (direct costs and quality‐adjusted life years). Analyses were by intention‐to‐treat using appropriate statistical tests. Results A total of 180 patients (mean age 55 years, 56.7% male) were randomized equally between groups. At 12 months, mean WOMAC pain was 15.2 (SD 8.4) in the guide‐plate group and 15.6 (SD 8.7) in controls, with no significant difference ( p = 0.74). The guide‐plate group showed significantly greater knee flexion (mean 128° vs. 122°; p = 0.04) and a higher 30‐s chair‐stand count (14.2 vs. 12.5 stands; p = 0.02) than controls. There were no other significant between‐group differences in clinical scores. Mean total cost per patient was not statistically significant in the ITT analysis ( p = 0.094). Quality‐adjusted life years did not differ between groups, yielding no cost‐effectiveness advantage. These findings echo prior reports that OWHTO techniques with higher costs have similar patient outcomes. Conclusion Using a 3D‐printed patient‐specific guide plate did not improve the primary pain outcome or overall functional outcome compared to standard OWHTO. It yielded minor gains in knee flexion and chair‐stand performance, but at greater cost. No overall cost‐effectiveness benefit was observed. Routine use of this technology for OWHTO is not supported by our findings. Level of Evidence Level I, randomized controlled trial. Trial Registration Chinese Clinical Trial Registry ( https://www.chictr.org.cn/ ): ChiCTR2000038619