The validity and accuracy of 3D-printed patient-specific instruments for high tibial osteotomy: a cadaveric study

Zhuang Miao, Songlin Li, Desu Luo, Qunshan Lu, Peilai Liu, Zhuang Miao, Songlin Li, Desu Luo, Qunshan Lu, Peilai Liu

Abstract

Objective: High tibial osteotomy (HTO) has been used for the treatment of patients with knee osteoarthritis. However, the successful implementation of HTO requires precise intraoperative positioning, which places greater requirements on the surgeon. In this study, we aimed to design a new kind of 3D-printed patient-specific instrument (PSI) for HTO, including a positioning device and an angle bracing spacer, and verify its effectiveness using cadaveric specimens.

Methods: This study included ten fresh human lower-limb cadaveric specimens. Computed tomography (CT) and X-ray examinations were performed to make preoperative plans. PSI was designed and 3D-printed according to the preoperative plan. Then, the PSI was used to guide HTO. Finally, we performed X-ray and CT after the operation to verify its validity and accuracy.

Results: The PSI using process was adjusted according to the pre-experimental procedure in 1 case. Hinge fracture occurred in 1 case. According to X-rays of the remaining eight cadaveric specimens, no statistically significant difference was noted between the preoperative planning medial proximal tibial angle (MPTA) and postoperative MPTA (P > 0.05) or the preoperative and postoperative posterior slope angle (PSA) (P > 0.05). According to the CT of 10 cadaveric specimens, no statistically significant difference was noted between the design angle and actual angle, which was measured according to the angle between the osteotomized line and the cross section (P > 0.05). The gap between the designed osteotomy line and the actual osteotomy line was 2.09 (0.8 ~ 3.44) mm in the coronal plane and 1.58 (0.7 ~ 2.85) mm in the sagittal plane.

Conclusion: This 3D-printed PSI of HTO accurately achieves the angle and position of the preoperative plan without increasing the stripping area. However, its use still requires a certain degree of proficiency to avoid complications, such as hinge fracture.

Keywords: 3D-printed; Accuracy; Cadaveric study; High tibial osteotomy; Patient-specific instrument; Validity.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Positioning device (Left: outside view; Right: inside view; From upper to bottom: the proximal positioning device, the force line bar and the distal positioning device)
Fig. 2
Fig. 2
Angular bracing spacer (left: side view; right: top view)
Fig. 3
Fig. 3
Design and 3D printing of PSI according to the preoperative plan and 3D skeletal model of the lower extremities (a perform CT examination. b CT scans were imported into Mimics 25.0 software to construct a 3D skeletal model of the lower limb. c The PSI was designed based on the preoperative plan and the 3D skeletal model of the lower extremities. d The PSI was 3D-printed)
Fig. 4
Fig. 4
HTO using PSI on a cadaveric specimen (a Positioning body surface markers. b PSI was positioned according to body surface markers and two Kirschner wires were fixed. c A biplanar osteotomy was performed along the predetermined osteotomy channel (red arrow) in the PSI. d Insert angular bracing spacer. e Plate was installed and secured with eight screws)
Fig. 5
Fig. 5
CT results of ten specimens (Red line: actual osteotomy line. Blue line: planning osteotomy line)

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