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Personalised HTO Versus Generic HTO Virtual Clinical Trial

NCT03419598 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-12-07

Study results available
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Summary

High Tibial Osteotomy (HTO) is an alternative to knee replacement in suitable patients with early knee osteoarthritis (OA), it is particularly suited to patients with single compart disease who otherwise would be suitable for unicompartmental knee replacement (UKR). OA of the knee is very common and increasing driven by the ageing of the population. The current limitations of HTO are related to the difficulty of achieving the desired correction due to a challenging surgical technique and soft tissue irritation due to the use of generic stabilisation plates. This study will examine the safety equivalence of a new patient specific HTO process which has patient specific 3D printed plates, i.e. personalised HTO plates, with the existing most commonly used HTO procedure using the Tomofix generic HTO plate. Importantly this study will be undertaken as a Virtual Trial, existing anonymised 3D imaging data will be used to create the virtual patient cohort. This cohort will receive both procedures, which for this type of procedure is only possible in a virtual scenario.

The main question to be addressed is: "Is the personalised HTO procedure as safe as the most commonly used existing generic HTO procedure?". In this context safety concerns the mechanical loads placed upon the tibia and the support plate.

The interventions will all be made on computer models, the 3D imaging data will be used to create the intact (un-operated) models of the subject tibias. Each model will then be virtually operated upon, with both the personalised and generic HTO procedures. The models will then be loaded with physiological loads experienced during function and the mechanical states compared.

Conditions

  • Osteoarthritis, Knee

Interventions

PROCEDURE

Opening wedge high tibial osteotomy

Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia. Since this is a virtual trial, the virtual patients were duplicated and enrolled into both arms

DEVICE

Personalised subject specific custom HTO plate

Subject specific custom plate for stabilizing an open wedge HTO

DEVICE

Generic HTO plate

Generic plate for stabilizing an open wedge HTO

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    collaborator OTHER

  • University of Bath

    lead OTHER

Principal Investigators

  • Richie Gill, DPhil · University of Bath

  • Andrew Toms, MD · Royal Devon & Exeter NHS Trust

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2019-06-28
Completion
2019-06-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03419598 on ClinicalTrials.gov