A Clinical Trial Examining the Accuracy of High Tibial Osteotomy When Performed by Experts Using a Novel Patient Specific Instrument (PSI)

2018 ◽  
Author(s):  
Gareth Jones ◽  
Martin Jaere ◽  
Susannah Clarke ◽  
Ronald van Heerwaarden ◽  
Adrian Wilson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Tibial Osteotomy ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Specific Instrument

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.

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 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 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

scholarly journals Is patient-specific instrumentation more precise than conventional techniques and navigation in achieving planned correction in high tibial osteotomy?

2020 ◽  
Vol 106 (8) ◽  
pp. S231-S236
Author(s):  
Nicolas Tardy ◽  
Camille Steltzlen ◽  
Nicolas Bouguennec ◽  
Jean-Loup Cartier ◽  
Patrice Mertl ◽  
...  
Keyword(s):  
High Tibial Osteotomy ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Patient Specific Instrumentation

THE PLANE RADIOGRAPH OF THE KNEE FOR HIGH TIBIAL OSTEOTOMY ASSESSMENT IS IN CONTRAST TO STANDING ALIGNMENT VIRTUALLY ELABORATED HANDLING BASED PRE-OPERATION PLANNING

2017 ◽  
Vol 29 (01) ◽  
pp. 1750001 ◽  
Author(s):  
Amir Hossein Saveh ◽  
Seyed Morteza Kazemi ◽  
Ali Reza Zali ◽  
Omid Dehpour ◽  
Minoo Tabandegan ◽  
...  
Keyword(s):  
Lower Extremity ◽  
High Tibial Osteotomy ◽  
Lower Limb ◽  
Gold Standard ◽  
Control Method ◽  
Weight Bearing ◽  
Fine Tuning ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Leg Length

High Tibial Osteotomy (HTO) is a popular approach among contemporary corrective lower extremity procedures. As a surgical method in the HTO, the Open-Wedge High Tibial Osteotomy (OWHTO) preserves leg length, avoids dissection near the nerve and allows for fine-tuning of the angle by gradually inserting a wedge into a tibia. Nowadays, the gold standard approach to the OWHTO is based on the patient’s Long-Leg Radiograph (LLR) assessment. These standard weight bearing views of the lower extremity have their own practical advantages. This study aims to closely look at existing gold standard OWHTO planning method and assess its accuracy compared to a true patient’s weight bearing posture. The study attempts to introduce a method which can be used as a template for the HTO planning and has less weakness than the existing method. This method will assess the lower limb weight bearing three-dimensionally using a patient specific Computer Tomography (CT) data. The method has been validated using a Standing Alignment Virtually Elaborated Handling (SAVEH) of the lower limb using fluoroscopy giving an in vivo dynamic weight bearing analysis of the knee. The outcome of typical examples on assessment of the natural mechanical axis of the knee using proposed method has shown more accuracy than common two-dimensional LLR image control method. The study concluded that looking at the OWHTO without any address of the real three-dimensional orientation of the knee bones specially during standing phase of gait may be a missing point of view on OWHTO surgery.

scholarly journals Customizable Patient-Specific Cutting Guide for High Tibial Osteotomy

2019 ◽  
Vol 71 (1) ◽  
pp. 49-54
Author(s):  
Radu Emanuil Petruse ◽  
Nicolae Florin Cofaru ◽  
Ileana Ioana Cofaru
Keyword(s):  
Articular Cartilage ◽  
Additive Manufacturing ◽  
High Tibial Osteotomy ◽  
Surgical Procedure ◽  
Surgical Intervention ◽  
Treatment Modalities ◽  
Patient Specific ◽  
Manufacturing Processes ◽  
Tibial Osteotomy ◽  
Inferior Limb

Abstract The paper is an interdisciplinary medical and engineering approach that aims to optimize the accuracy of the High Tibial Osteotomy surgical intervention. The axial deviations of the human inferior limb are presented in the first part of the paper. Without altering the shape of the bones, these deviations cause the wear of the knee’s articular cartilage by gonarthrosis. One of the most common and effective treatment modalities for eliminating axial deviations is High Tibial Osteotomy. Because the surgical procedure involves 3D spatial bone cutting, the accuracy of the procedure and thus the success of the operation and the recovery of the patient is dependent on the execution of these cuts. Within this paper, a specialized device is proposed that makes it possible to guide the surgical saw and to accurately perform the correction angles. In the last part of the paper, customization possibilities and fabrication of the main elements of the cutting device using Additive Manufacturing processes are presented.

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