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"

926 54 13608 11 42372 document 13608 data_files.zip application/zip 98ff1921a5f80ce4eab0727a7f23cd75 MD5 1054493 2020-10-19 16:05:45 https://researchdata.bath.ac.uk/926/1/data_files.zip 926 1 1 application/zip other 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). en public cc_by

data_files.zip

data 13609 2 42380 document 13609 219877 SL45_(Approval)_Letter_of_HRA_Approval.pdf application/pdf 22429cf9e526f5241138f0cb392a3ba6 MD5 164517 2020-10-19 16:38:29 https://researchdata.bath.ac.uk/926/2/219877%20SL45_%28Approval%29_Letter_of_HRA_Approval.pdf 926 2 2 application/pdf other en staffonly all_rights_reserved

219877 SL45_(Approval)_Letter_of_HRA_Approval.pdf

ethics 13610 1 42384 document 13610 indexcodes.txt text/x-c++ d9b9627823cda956fdc56cb6dc9fc920 MD5 3148 2020-10-19 17:47:26 https://researchdata.bath.ac.uk/926/3/indexcodes.txt 926 3 3 text/x-c++ other Generate index codes conversion from other to indexcodes en staffonly

indexcodes.txt

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http://eprints.org/relation/isVersionOf https://researchdata.bath.ac.uk/id/document/13609 http://eprints.org/relation/isVolatileVersionOf https://researchdata.bath.ac.uk/id/document/13609 http://eprints.org/relation/issmallThumbnailVersionOf https://researchdata.bath.ac.uk/id/document/13609 13615 8 42390 document 13615 vtrial18Nov19.mat application/octet-stream e2f0fd9892934bd42d5e6f6839e6b63a MD5 708985 2020-10-19 21:38:54 https://researchdata.bath.ac.uk/926/8/vtrial18Nov19.mat 926 8 8 application/octet-stream other 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). en public cc_by

vtrial18Nov19.mat

data 13616 5 42392 document 13616 Matlab_processing_files.zip application/zip 26934e0c09d0f740f0745611cbadd381 MD5 30974 2020-10-19 21:41:27 https://researchdata.bath.ac.uk/926/9/Matlab_processing_files.zip 926 9 9 application/zip other Matlab code to process data for presentation in vtrial data structure. en public cc_gnu_gpl

Matlab_processing_files.zip

code 13617 3 42396 document 13617 DMP_VirtualTrial_Toka.docx application/vnd.openxmlformats-officedocument.wordprocessingml.document ea016edc22dc6065a1feebe7e32c941d MD5 17631 2020-10-19 21:45:41 https://researchdata.bath.ac.uk/926/10/DMP_VirtualTrial_Toka.docx 926 10 10 application/vnd.openxmlformats-officedocument.wordprocessingml.document other en staffonly all_rights_reserved

DMP_VirtualTrial_Toka.docx

dmp 13618 1 42399 document 13618 indexcodes.txt text/x-c++ 8a92f1c43f2641def19db84e26ede302 MD5 2467 2020-10-19 21:49:15 https://researchdata.bath.ac.uk/926/11/indexcodes.txt 926 11 11 text/x-c++ other Generate index codes conversion from other to indexcodes en validuser

indexcodes.txt

http://eprints.org/relation/isVersionOf https://researchdata.bath.ac.uk/id/document/13617 http://eprints.org/relation/isVolatileVersionOf https://researchdata.bath.ac.uk/id/document/13617 http://eprints.org/relation/isIndexCodesVersionOf https://researchdata.bath.ac.uk/id/document/13617 13619 3 42410 document 13619 postprocessing.zip application/zip ff17b1ade5d7ed16c8618b182730c0e0 MD5 5256336 2020-10-21 20:31:12 https://researchdata.bath.ac.uk/926/12/postprocessing.zip 926 12 12 application/zip other Combination of Matlab and ANSYS APLD code to extract Von Mises stresses for HTO plates, bones strains and node displacements for fracture gap from ANSYS results files. Requires ‘grep’ so will only work on Linux platform. en invisible all_rights_reserved

postprocessing.zip

code 14786 7 46067 document 14786 Muscle&JointForceVectorsAllCasesVTrial.zip application/zip ed7b06fb72ade214889d876d49904c4e MD5 374791 2021-03-24 09:37:59 https://researchdata.bath.ac.uk/926/13/Muscle%26JointForceVectorsAllCasesVTrial.zip 926 13 13 application/zip other 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. en public cc_by

Muscle&JointForceVectorsAllCasesVTrial.zip

data 14788 7 46072 document 14788 TransformationScalingScripts.zip application/zip ae611e883abda7d3aeb54d4e39fd977f MD5 445272 2021-03-24 09:49:52 https://researchdata.bath.ac.uk/926/14/TransformationScalingScripts.zip 926 14 14 application/zip other Transformation and scaling scripts to register muscle force vector data to each virtual patient. en public cc_gnu_gpl

TransformationScalingScripts.zip

code 14790 6 46097 document 14790 MacLeod_2018_HTO_Model.zip application/zip da60e82d3937636f5491eacec8d8a8fe MD5 43420187 2021-03-25 00:30:13 https://researchdata.bath.ac.uk/926/15/MacLeod_2018_HTO_Model.zip 926 15 15 application/zip other 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 en public cc_by

MacLeod_2018_HTO_Model.zip

data archive 3826 disk0/00/00/09/26 2021-04-15 13:27:16 2024-07-04 14:13:19 2021-04-15 13:27:16 data_collection show Gill Richie R.Gill@bath.ac.uk 0000-0002-7740-2062 University of Bath TRUE MacLeod Alisdair A.Macleod@bath.ac.uk 0000-0001-6981-8087 University of Bath FALSE Toms Andrew andrewtoms@nhs.net Royal Devon and Exeter NHS Foundation Trust FALSE 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" GS0020 KS0080 KS0110 dept_mech_eng In silico clinical trial, personalised HTO, physiological loads, finite element modelling, 3D printed 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 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. 2021-04-15 University of Bath public 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. RightsHolder University of Bath Arthritis Research UK https://doi.org/10.13039/501100000341 21495 ToKa: A High Precision Patient Specific High Tibial Osteotomy Procedure Versus Arthritis https://doi.org/10.13039/501100012041 22262 PASHiOn: Personalised Against Standard High tibial Osteotomy Randomised Control Trial bathcti 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. The data was processed in Matlab (v2017b) to obtain the peak values. ANSYS R18.2 Matlab v2017b 2017-01-01 2020-01-30 UK, Southwest, Bath & Exeter en 1 10.15125/BATH-00926 https://doi.org/10.1038/s43856-021-00001-7 pub Balena High Performance Computing (HPC) System 3e22ef13-31b9-4700-b57e-57bcd3b3b985 open The files are embargoed until 28 May 2021, after which they will be publicly available under licence.