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

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.

scholarly journals Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041129
Author(s):  
Lawrence Chun Man Lau ◽  
Elvis Chun Sing Chui ◽  
Jason Chi Ho Fan ◽  
Gene Chi Wai Man ◽  
Yuk Wah Hung ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
High Tibial Osteotomy ◽  
Controlled Trial ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Double Blind ◽  
Patient Specific Instrumentation ◽  
3D Printed ◽  
Randomised Controlled

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.

scholarly journals Clinical Experience Using a 3D-Printed Patient-Specific Instrument for Medial Opening Wedge High Tibial Osteotomy

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Jesse Chieh-Szu Yang ◽  
Cheng-Fong Chen ◽  
Chu-An Luo ◽  
Ming-Chau Chang ◽  
Oscar K. Lee ◽  
...  
Keyword(s):  
High Tibial Osteotomy ◽  
Weight Bearing ◽  
Ct Scanning ◽  
Tibial Slope ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Opening Wedge ◽  
Time Saving ◽  
X Ray ◽  
Specific Instrument

Purpose. High tibial osteotomy (HTO) has been adopted as an effective surgery for medial degeneration of the osteoarthritis (OA) knee. However, satisfactory outcomes necessitate the precise creation and distraction of osteotomized wedges and the use of intraoperative X-ray images to continually monitor the wedge-related manipulation. Thus HTO is highly technique-demanding and has a high radiation exposure. We report a patient-specific instrument (PSI) guide for the precise creation and distraction of HTO wedge. Methods. This study first parameterized five HTO procedures to serve as a design rationale for an innovative PSI guide. Preoperative X-ray and computed tomography- (CT-) scanning images were used to design and fabricate PSI guides for clinical use. The weight-bearing line (WBL) of the ten patients was shifted to the Fujisawa’s point and instrumented using the TomoFix system. The radiological results of the PSI-guided HTO surgery were evaluated by the WBL percentage and tibial slope. Results. All patients consistently showed an increased range of motion and a decrease in pain and discomfort at about three-month follow-up. This study demonstrates the satisfactory accuracy of the WBL adjustment and tibial slope maintenance after HTO with PSI guide. For all patients, the average pre- and postoperative WBL are, respectively, 14.2% and 60.2%, while the tibial slopes are 9.9 and 10.1 degrees. The standard deviations are 2.78 and 0.36, respectively, in postoperative WBL and tibial slope. The relative errors of the pre- and postoperative WBL percentage and tibial slope averaged 4.9% and 4.1%, respectively. Conclusion. Instead of using navigator systems, this study integrated 2D and 3D preoperative planning to create a PSI guide that could most likely render the outcomes close to the planning. The PSI guide is a precise procedure that is time-saving, radiation-reducing, and relatively easy to use. Precise osteotomy and good short-term results were achieved with the PSI guide.

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

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

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

The Knee ◽  
2020 ◽  
Vol 27 ◽  
pp. S8
Author(s):  
J. Mathews ◽  
A. MacLeod ◽  
A. Toms ◽  
R. Gill ◽  
A. Casonato ◽  
...  
Keyword(s):  
High Tibial Osteotomy ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Preclinical Stage ◽  
3D Printed

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

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.

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

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.

scholarly journals Minimally Invasive High Tibial Osteotomy Using a Patient-Specific Cutting Guide

2021 ◽  
Vol 10 (2) ◽  
pp. e431-e435
Author(s):  
Hamid Rahmatullah Bin Abd Razak ◽  
Christophe Jacquet ◽  
Adrian J. Wilson ◽  
Raghbir S. Khakha ◽  
Kristian Kley ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
High Tibial Osteotomy ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Cutting Guide

Assessing the Local Mechanical Environment in Medial Opening Wedge High Tibial Osteotomy Using Finite Element Analysis

2015 ◽  
Vol 137 (3) ◽  
Author(s):  
Yves Pauchard ◽  
Todor G. Ivanov ◽  
David D. McErlain ◽  
Jaques S. Milner ◽  
J. Robert Giffin ◽  
...  
Keyword(s):  
Finite Element ◽  
High Tibial Osteotomy ◽  
Volume Fraction ◽  
Compressive Strain ◽  
Tibial Osteotomy ◽  
Fe Modeling ◽  
Knee Alignment ◽  
Mechanical Environment ◽  
Significant Difference ◽  
Subject Specific

High-tibial osteotomy (HTO) is a surgical technique aimed at shifting load away from one tibiofemoral compartment, in order the reduce pain and progression of osteoarthritis (OA). Various implants have been designed to stabilize the osteotomy and previous studies have been focused on determining primary stability (a global measure) that these designs provide. It has been shown that the local mechanical environment, characterized by bone strains and segment micromotion, is important in understanding healing and these data are not currently available. Finite element (FE) modeling was utilized to assess the local mechanical environment provided by three different fixation plate designs: short plate with spacer, long plate with spacer and long plate without spacer. Image-based FE models of the knee were constructed from healthy individuals (N = 5) with normal knee alignment. An HTO gap was virtually added without changing the knee alignment and HTO implants were inserted. Subsequently, the local mechanical environment, defined by bone compressive strain and wedge micromotion, was assessed. Furthermore, implant stresses were calculated. Values were computed under vertical compression in zero-degree knee extension with loads set at 1 and 2 times the subject-specific body weight (1 BW, 2 BW). All studied HTO implant designs provide an environment for successful healing at 1 BW and 2 BW loading. Implant von Mises stresses (99th percentile) were below 60 MPa in all experiments, below the material yield strength and significantly lower in long spacer plates. Volume fraction of high compressive strain ( > 3000 microstrain) was below 5% in all experiments and no significant difference between implants was detected. Maximum vertical micromotion between bone segments was below 200 μm in all experiments and significantly larger in the implant without a tooth. Differences between plate designs generally became apparent only at 2 BW loading. Results suggest that with compressive loading of 2 BW, long spacer plates experience the lowest implant stresses, and spacer plates (long or short) result in smaller wedge micromotion, potentially beneficial for healing. Values are sensitive to subject bone geometry, highlighting the need for subject-specific modeling. This study demonstrates the benefits of using image-based FE modeling and bone theory to fine-tune HTO implant design.

scholarly journals Hybrid Spine Simulator Prototype for X-ray Free Pedicle Screws Fixation Training

2021 ◽  
Vol 11 (3) ◽  
pp. 1038
Author(s):  
Sara Condino ◽  
Giuseppe Turini ◽  
Virginia Mamone ◽  
Paolo Domenico Parchi ◽  
Vincenzo Ferrari
Keyword(s):  
Augmented Reality ◽  
Low Cost ◽  
Lumbar Vertebrae ◽  
Pedicle Screws ◽  
Simulation Software ◽  
Patient Specific ◽  
Innovative Strategy ◽  
X Ray ◽  
3D Printed ◽  
Harmful Radiation

Simulation for surgical training is increasingly being considered a valuable addition to traditional teaching methods. 3D-printed physical simulators can be used for preoperative planning and rehearsal in spine surgery to improve surgical workflows and postoperative patient outcomes. This paper proposes an innovative strategy to build a hybrid simulation platform for training of pedicle screws fixation: the proposed method combines 3D-printed patient-specific spine models with augmented reality functionalities and virtual X-ray visualization, thus avoiding any exposure to harmful radiation during the simulation. Software functionalities are implemented by using a low-cost tracking strategy based on fiducial marker detection. Quantitative tests demonstrate the accuracy of the method to track the vertebral model and surgical tools, and to coherently visualize them in either the augmented reality or virtual fluoroscopic modalities. The obtained results encourage further research and clinical validation towards the use of the simulator as an effective tool for training in pedicle screws insertion in lumbar vertebrae.

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