Dataset for "Personalised HTO with patient specific plates has mechanical safety equivalent to generic HTO: findings from a novel case-control in silico clinical trial"

In real clinical trials it is difficult, if not impossible, to give the same patient two different orthopaedic implants for treatment of a single joint. Thus real clinical trials have to find controls, and it is very difficult to ensure that controls and cases are well matched. We performed a virtual clinical trial, using computer representations of the shin-bones of real patients. These were operated on virtually to simulate what happens in a type of surgery called High Tibial Osteotomy (HTO) which treats early knee osteoarthritis; this surgery makes a cut in the bone to re-align the bone and needs a metal plate to stablise the cut during healing. We then duplicated the patients and stablised one copy with a generic plate and the other copy with a new personalised plate. We performed computer simulation to calculate the forces in the plates during normal activities (walking, chair rise and squat) to assess whether the new personalised plates had any difference in terms of mechanical safety. The data given here are the main findings.

To compare the mechanical safety of a new personalised 3D printed high tibial osteotomy (HTO) device with an existing generic device, a novel case-control in silico virtual clinical trial was conducted (ClinicalTrial.gov NCT03419598). Twenty-eight knee osteoarthritis patients underwent 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, simulating 2, 4 and 12 weeks after surgery.

The dataset includes the demographic information of the subjects, the applied loads, the summarised output data from the finite element models, namely the maximum Von Mises stress (MPa) in the plate and the maximum Von Mises strain (unitless) in the tibial bone adjacent to the screws holding the plate to the tibia.

Keywords:
In silico clinical trial, personalised HTO, physiological loads, finite element modelling, 3D printed
Subjects:
Medical and health interface
Tools, technologies and methods

Cite this dataset as:
Gill, R., MacLeod, A., Toms, A., 2021. Dataset for "Personalised HTO with patient specific plates has mechanical safety equivalent to generic HTO: findings from a novel case-control in silico clinical trial". Bath: University of Bath Research Data Archive. Available from: https://doi.org/10.15125/BATH-00926.

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Data

data_files.zip
application/zip (1MB)
Creative Commons: Attribution 4.0

Zip file containing data from the virtual trial as txt files and CSV files. SupplementaryInformation.docx gives the demographics of the cohort, material properties used for the healing stages, loads applied to models, and main results in terms of contingency table for number of load cases where maximum stress exceeded the fatigue limit, and summarised data for Von Mises stress (MPa) in the plate, Von Mises strain (unitless) in the bone and the interfragmentary motion (mm).

vtrial18Nov19.mat
application/octet-stream (708kB)
Creative Commons: Attribution 4.0

Extracted output data stored in Matlab data structure. Contains [1×30] structure ‘vtrial’, which contains [1×2] character ‘patient’ (01 to 30, gives patientID) and [1×2] structure ‘dev’ ([1] for TOMOFIX, [2] for TOKA). The structure ‘dev’ contains [1×7] character ‘name’ and [1×3] structure ‘sc’ (screw configurations 1 to 3). The structure ‘sc’ contains [1×2] structure ‘hs’ (healing stages 2, 3, 4). The structure ‘hs’ contains [0×0] double-precision array ‘lstep’ (loadsteps 1 to 15).

Muscle&JointFor … CasesVTrial.zip
application/zip (374kB)
Creative Commons: Attribution 4.0

Force Vector and Joint Reaction Data. The transformed and scaled data for each virtual patient is in the patient folder directory named in the format ‘PX’ where X denotes the patient number. Within each patient folder, there are 3 sub directories or activity folders: (a) FastGait, (b) Squat, (c) ChairRise. Each activity folder contains various .csv files; for descriptions see "Force Vector & Joint Reaction Data.docx" in top level of directory tree.

MacLeod_2018_HTO_Model.zip
application/zip (43MB)
Creative Commons: Attribution 4.0

Finite element models developed using a composite tibia (third-generation Sawbones model 3302, Biomechanical Test Materials; Pacific Research Laboratories, Malmö, Sweden). A high tibial osteotomy model was created using this geometry and is referenced in MacLeod, A R, et al. (2019), "The effect of plate design, bridging span, and fracture healing on the performance of high tibial osteotomy plates: an experimental and finite element study," DOI: 10.1302/2046-3758.712.BJR-2018-0035.R1

Code

Matlab_processing_files.zip
application/zip (30kB)
Software: GNU GPL 3.0

Matlab code to process data for presentation in vtrial data structure.

TransformationScalingScripts.zip
application/zip (445kB)
Software: GNU GPL 3.0

Transformation and scaling scripts to register muscle force vector data to each virtual patient.

The files are embargoed until 28 May 2021, after which they will be publicly available under licence.

Creators

Richie Gill
University of Bath

Andrew Toms
Royal Devon & Exeter NHS Foundation Trust

Contributors

University of Bath
Rights Holder

Coverage

Collection date(s):

From 1 January 2017 to 30 January 2020

Geographical coverage:

UK, Southwest, Bath & Exeter

Documentation

Data collection method:

Data from case-control in silico clinical trial aimed at assessing the mechanical safety of a personalised high tibial osteotomy plate. Data is generated from finite element models created and solved using ANSYS R18.2. The primary outcome was the peak Von Mises stress (MPa) in the plate, the secondary values were the peak Von Mises strain in bone where the screws holding the plates were located and the interfragmentary motion of fracture gap. All these were extracted from the ANSYS results file using APLD commands to extract the data of interest. The data was in the form of Von Mises stress and Von Mises strain from all relevant nodes.

Data processing and preparation activities:

The data was processed in Matlab (v2017b) to obtain the peak values.

Technical details and requirements:

ANSYS R18.2 Matlab v2017b

Additional information:

Summary data described in meta-data, stored as plain text format Matlab data file stores vtrial data structure, self-documented and further documented in meta-data

Funders

ToKa: A High Precision Patient Specific High Tibial Osteotomy Procedure
21495

PASHiOn: Personalised Against Standard High tibial Osteotomy Randomised Control Trial
22262

Publication details

Publication date: 15 April 2021
by: University of Bath

Version: 1

DOI: https://doi.org/10.15125/BATH-00926

URL for this record: https://researchdata.bath.ac.uk/id/eprint/926

Related papers and books

MacLeod, A. R., Peckham, N., Serrancolí, G., Rombach, I., Hourigan, P., Mandalia, V. I., Toms, A. D., Fregly, B. J. and Gill, H. S., 2021. Personalised high tibial osteotomy has mechanical safety equivalent to generic device in a case–control in silico clinical trial. Communications Medicine, 1(1). Available from: https://doi.org/10.1038/s43856-021-00001-7.

Contact information

Please contact the Research Data Service in the first instance for all matters concerning this item.

Contact person: Richie Gill

Departments:

Faculty of Engineering & Design
Mechanical Engineering

Research Centres & Institutes
Centre for Therapeutic Innovation