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

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.

A new three‐dimensional patient‐specific cutting guide for opening wedge high tibial osteotomy based on ct scan: preliminary in vitro results

“…The authors concluded about a high accuracy of the system, with Pearson's correlation coefficient values similar to those obtained in this study [14]. Miao et al evaluated the accuracy of an angular spacer on 8 specimens, with no significant differences in planned and post-operative MPTA [17]. However, CT scan measurements were performed separately and not superimposed, which may induce doubts in the validity of the comparison.…”

“…Recently 3D patient-specific cutting guides (PSCG) based on Computer Tomography (CT) scans were developed. Preliminary in vitro studies described very good accuracy for some PSCG systems on both the coronal and sagittal plane [14][15][16][17].…”

Custom-Made Devices Represent a Promising Tool to Increase Correction Accuracy of High Tibial Osteotomy: A Systematic Review of the Literature and Presentation of Pilot Cases with a New 3D-Printed System

“…An additional study was excluded because it investigated the osteotomy procedure to correct tibial plateau fractures’ non-union [ 12 ]. A total of 28 articles [ 6 , 7 , 8 , 9 , 10 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 ] were included in this systematic review ( Figure 1 ).…”

“…Cadaveric studies investigating the accuracy of patient-specific 3D-printed device for HTO have risen in recent years [ 8 , 9 , 15 , 26 ], reporting a mean difference between planned and achieved medial proximal tibial angle (MPTA) under 1° ( Table 3 ). These favorable results have also been confirmed in in vivo studies ( Table 2 a).…”

“…The most investigated aspect of a patient-specific 3D device applied to HTO surgery was the cutting guide ( Table 1 ), which plays a key role in translating the pre-operative 3D surgical planning to the operating room. While some cutting guides use distant bony landmarks [ 7 , 26 ] aiming for a smaller skin incision, most cutting guides described in the literature rely on local bone references. Other customized devices for HTO reported in the literature are the spacer wedge blocks [ 9 , 22 , 24 , 28 , 34 ].…”