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Published on: June 6, 2025
Development and clinical application of a positioning device for the distal femoral closing wedge osteotomy
Daizhu Yuan1, Zhanyu Wu1, Zihao Zou1
1Department of Orthopaedics and Sport Medicine, The Affiliated Hospital of Guizhou Medical University, Guiyang, 550004, China; Center for Tissue Engineering and Stem Cells, Guizhou Medical University, Guiyang, 550004, China.
Background:
The distal femoral closing wedge osteotomy is a common method for treating the femoral deformity in knee osteoarthritis. However, due to the lack of appropriate surgical devices, there are shortcomings: difficulty of positioning hinge area, complex calculation of corrective angle, and hinge damage. This study aimed to develop a positioning device to solve the above problems.
Methods:
Computer-aided design software and three dimensional (3D) printer were used to design, modify, and print the novel device. The Sawbones experiment was used for functional verification and preliminary clinical application was conducted to evaluate the effectiveness of the device.
Results:
In the Sawbones experiment, with assistance of the novel device, the angle of the first positioning was more accurate than the conventional method (p < 0.05) and retained the fixed hinge width (p < 0.05). In preliminary clinical application, the average time for accurate positioning hinge was 75s and the average fluoroscopy was 2 times. Hinge fracture occurred in 1 case. The average operation time was 47 min. The hip-knee-ankle angle (HKA) improved from preoperative (171.16 ± 2.65°) to postoperative (180.55 ± 1.21°) (p < 0.01) and the mechanical lateral distal femoral angle (mLDFA) was significantly improved compared with the pre-operation (94.45 ± 1.26° vs 87.31 ± 1.10°, p < 0.01). The angle between the anatomic axis of the femur and the Blumensaat's line (AFBL) was no statistically significant difference compared with the pre-operation (p > 0.05). After 9 months, the american knee society score (AKSS) was from preoperative (63.64 ± 4.74) to postoperative (92.82 ± 2.71) (p < 0.01) and Lysholm score was significantly improved (56.82 ± 5.38 vs 91.27 ± 2.24, p < 0.01). The pain symptoms were relieved and the visual analogue scales (VAS) was significantly reduced compared with the pre-operation (p < 0.01).
Conclusions:
The positioning device had the functions of calculation-free of corrective angle and hinge retention, which was an efficient device for the distal femoral closing wedge osteotomy.
