PERSONALISING HIGH TIBIAL OSTEOTOMY: ‘IDEAL’ PRECLINICAL STAGE EVALUATION OF TOKA® - A NOVEL PATIENT SPECIFIC 3D PRINTED SYSTEM

IntroductionHigh tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing, patient-specific instrumentation (PSI) in form of cutting jigs is employed to improve surgical accuracy and outcome of HTO. The aim of this randomised controlled trial (RCT) is to explore the surgical outcomes of HTO for the treatment of medial compartment knee osteoarthritis with or without a 3D printed patient-specific jig.Methods and analysisA double-blind RCT will be conducted with patients and outcome assessors blinded to treatment allocation. This meant that neither the patients nor the outcome assessors would know the actual treatment allocated during the trial. Thirty-six patients with symptomatic medial compartment knee osteoarthritis fulfilling our inclusion criteria will be invited to participate the study. Participants will be randomly allocated to one of two groups (1:1 ratio): operation with 3D printed patient-specific jig or operation without jig. Measurements will be taken before surgery (baseline) and at postoperatively (6, 12 and 24 months). The primary outcome includes radiological accuracy of osteotomy. Secondary outcomes include a change in knee function from baseline to postoperatively as measured by three questionnaires: Knee Society Scores (Knee Scores and Functional Scores), Oxford Knee Scores and pain visual analogue scale (VAS) score.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (CREC no. 2019.050), in accordance with the Declaration of Helsinki. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numberNCT04000672; Pre-results.

Download Full-text

Using a Patient-Specific 3D-Printed Surgical Guide for High Tibial Osteotomy: A Technical Note

Journal of Shanghai Jiaotong University (Science) ◽

10.1007/s12204-021-2302-8 ◽

2021 ◽

Vol 26 (3) ◽

pp. 339-345

Author(s):

Xu Jiang ◽

Kai Xie ◽

Bo Li ◽

Xumin Hu ◽

Haishan Wu ◽

...

Keyword(s):

High Tibial Osteotomy ◽

Technical Note ◽

Patient Specific ◽

Tibial Osteotomy ◽

Surgical Guide ◽

3D Printed

Download Full-text

The Validity and Accuracy of 3D-printed Patient-specific Instruments for High Tibial Osteotomy: A Cadaveric Study

10.21203/rs.3.rs-1163643/v1 ◽

2021 ◽

Author(s):

Zhuang Miao ◽

Songlin Li ◽

Desu Luo ◽

Qunshan Lu ◽

Peilai Liu

Keyword(s):

High Tibial Osteotomy ◽

Patient Specific ◽

Successful Implementation ◽

Tibial Osteotomy ◽

X Ray ◽

Significant Difference ◽

3D Printed ◽

Osteotomy Line ◽

Preoperative Plan ◽

Hinge Fracture

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 use 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 8 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.

Download Full-text

Opening Wedge High Tibial Osteotomy with Combined Use of Patient-Specific 3D-Printed Plates and Taylor Spatial Frame for the Treatment of Knee Osteoarthritis

Pain Research and Management ◽

10.1155/2021/8609921 ◽

2021 ◽

Vol 2021 ◽

pp. 1-6

Author(s):

Desheng Duan ◽

Yang Cao ◽

Renzeng Li ◽

Guohui Wang ◽

Yongfei Zhang ◽

...

Keyword(s):

Knee Joint ◽

High Tibial Osteotomy ◽

Patient Specific ◽

Tibial Osteotomy ◽

Varus Alignment ◽

Opening Wedge ◽

Knee Oa ◽

Wedge High Tibial Osteotomy ◽

3D Printed ◽

The Difference

Background. High tibial osteotomy (HTO) is used to treat medial degeneration of the osteoarthritis (OA) knee. However, shortcomings still exist in the current procedure, like unprecise creation, inability to correct knee rotation, and internal fixed failure. Here, we reported a novel procedure: patient-specific 3D-printed plates for opening wedge high tibial osteotomy (OWHTO) combined with Taylor spatial frame (TSF). The detailed technique was described, and the clinical outcomes were evaluated. Methods. We prospectively evaluate outcomes of patient-specific 3D-printed plates for OWHTO with use of TSF in 25 patients with knee OA and varus alignment. Postoperative efficacy was evaluated using the HSS knee score, pain visual simulation score (VAS), and knee joint motion (ROM), and lower limb alignment was evaluated by measuring femorotibial angle (FTA) and hip-knee-ankle (HKA). Results and Conclusion. All patients did not experience complications such as wound infection, nerve damage, or bone amputation. 25 patients were followed up for 6–18 months. The bony union at bone amputation was achieved in 3 months after surgery, and the pain symptoms were significantly alleviated or disappeared. The VAS score was significantly reduced in 6 months after surgery compared with preoperative; the HSSS score was significantly added in 6 months after surgery compared with preoperative. The ROM of knee joint increased significantly 6 months after operation compared with that before operation, and the difference was statically significant ( P < 0.05 ). The FTA and HKA after operation were significantly superior to that before operation, and the difference was statically significant ( P < 0.01 ). Conclusions. Our study showed that patient-specific 3D-printed plates for HTO with the use of TSF have the advantages of small trauma, few complications, simple operation, and fast recovery in treating knee OA and varus alignment.

Download Full-text

Personalised high tibial osteotomy has mechanical safety equivalent to generic device in a case–control in silico clinical trial

Communications Medicine ◽

10.1038/s43856-021-00001-7 ◽

2021 ◽

Vol 1 (1) ◽

Author(s):

Alisdair R. MacLeod ◽

Nicholas Peckham ◽

Gil Serrancolí ◽

Ines Rombach ◽

Patrick Hourigan ◽

...

Keyword(s):

Clinical Trial ◽

Relative Risk ◽

Knee Osteoarthritis ◽

High Tibial Osteotomy ◽

Fatigue Failure ◽

In Silico ◽

Odds Ratio ◽

Case Control ◽

Tibial Osteotomy ◽

3D Printed

Abstract Background Despite favourable outcomes relatively few surgeons offer high tibial osteotomy (HTO) as a treatment option for early knee osteoarthritis, mainly due to the difficulty of achieving planned correction and reported soft tissue irritation around the plate used to stablise the osteotomy. To compare the mechanical safety of a new personalised 3D printed high tibial osteotomy (HTO) device, created to overcome these issues, with an existing generic device, a case-control in silico virtual clinical trial was conducted. Methods Twenty-eight knee osteoarthritis patients underwent computed tomography (CT) scanning to create a virtual cohort; the cohort was duplicated to form two arms, Generic and Personalised, on which virtual HTO was performed. Finite element analysis was performed to calculate the stresses in the plates arising from simulated physiological activities at three healing stages. The odds ratio indicative of the relative risk of fatigue failure of the HTO plates between the personalised and generic arms was obtained from a multi-level logistic model. Results Here we show, at 12 weeks post-surgery, the odds ratio indicative of the relative risk of fatigue failure was 0.14 (95%CI 0.01 to 2.73, p = 0.20). Conclusions This novel (to the best of our knowledge) in silico trial, comparing the mechanical safety of a new personalised 3D printed high tibial osteotomy device with an existing generic device, shows that there is no increased risk of failure for the new personalised design compared to the existing generic commonly used device. Personalised high tibial osteotomy can overcome the main technical barriers for this type of surgery, our findings support the case for using this technology for treating early knee osteoarthritis.

Download Full-text