Evidence map›Paper›PMID 35602226›Full record

ArticleCommunications medicine2021

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

Alisdair R MacLeod, Nicholas Peckham, Gil Serrancolí, Ines Rombach, Patrick Hourigan, Vipul I Mandalia, Andrew D Toms, Benjamin J Fregly, Harinderjit S Gill

Open access · goldAbstract read
In one paragraph

Article in Communications medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 3 countries.

Alisdair R MacLeodDepartment of Mechanical Engineering, University of Bath, Bath, UK.ORCID 0000-0001-6981-8087
Nicholas PeckhamOxford Clinical Trials Research Unit, NDORMS, University of Oxford, Oxford, UK.ORCID 0000-0003-1066-0726
Gil SerrancolíDepartment of Mechanical Engineering, Polytechnic University of Catalonia, Barcelona, Catalunya Spain.ORCID 0000-0001-5034-2445
Ines RombachOxford Clinical Trials Research Unit, NDORMS, University of Oxford, Oxford, UK.
Patrick HouriganRoyal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Vipul I MandaliaRoyal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Andrew D TomsRoyal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Benjamin J FreglyDepartment of Mechanical Engineering, Rice University, Houston, TX USA.
Harinderjit S GillDepartment of Mechanical Engineering, University of Bath, Bath, UK.ORCID 0000-0002-7740-2062
Royal Devon & Exeter NHS Foundation Trust · GBUniversity of Bath · GBUniversity of Oxford · GBRice University · USUniversitat Politècnica de Catalunya · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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, 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.

Indexed as

Health careMedical research

Identifiers

PMID35602226
PMCPMC9053187
OpenAlexW3158209598

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.