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ToKa HTO Versus Generic HTO Virtual Clinical Trial

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ClinicalTrials.gov Identifier: NCT03419598
Recruitment Status : Unknown
Verified January 2018 by Richie Gill, University of Bath.
Recruitment status was:  Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Royal Devon and Exeter NHS Foundation Trust
Information provided by (Responsible Party):
Richie Gill, University of Bath

Tracking Information
First Submitted Date  ICMJE January 26, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date February 5, 2018
Actual Study Start Date  ICMJE January 3, 2017
Estimated Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
Mechanical stress in plate [ Time Frame: 6 weeks simulated post-operation ]
Mechanical strain calculated for functional loading using finite element analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
Mechanical strain in bone around screws [ Time Frame: 6 weeks simulated post-operation ]
Mechanical strain calculated for functional loading using finite element analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ToKa HTO Versus Generic HTO Virtual Clinical Trial
Official Title  ICMJE ToKa Subject Specific HTO Versus Generic HTO Virtual Clinical Trial
Brief 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, ToKa, with the existing most commonly used HTO procedure using the Tomofix 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 ToKa procedure as safe as the most commonly used existing 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 ToKa and Tomofix procedures. The models will then be loaded with physiological loads experienced during function and the mechanical states compared.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a virtual clinical trial, virtual cohort generated from anonymised imaging data from patients with osteoarthritis of the knee
Masking: None (Open Label)
Masking Description:
This virtual trial allows all participants to receive both treatments, i.e. HTO using existing generic technique and HTO using novel subject specific technique
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Procedure: Opening wedge high tibial osteotomy
    Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia
    Other Name: HTO
  • Device: ToKa subject specific custom HTO plate
    Subject specific custom plate for stabilizing an open wedge HTO
    Other Name: ToKa plate
  • Device: Generic HTO plate
    Generic plate for stabilizing an open wedge HTO
    Other Name: Generic plate
Study Arms  ICMJE
  • Experimental: ToKa HTO

    Opening wedge high tibial osteotomy

    ToKa subject specific custom HTO plate

    Interventions:
    • Procedure: Opening wedge high tibial osteotomy
    • Device: ToKa subject specific custom HTO plate
  • Active Comparator: Generic HTO

    Opening wedge high tibial osteotomy

    Generic HTO plate

    Interventions:
    • Procedure: Opening wedge high tibial osteotomy
    • Device: Generic HTO plate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 26, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2018
Estimated Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Appropriate existing CT data of lower limb.
  • Male or Female, aged 18 years or above.
  • Diagnosed with moderate to severe OA of the knee.

Exclusion Criteria:

  • Abnormal anatomy of tibia or presence of pathology other than OA, e.g. bone tumour.
  • Previous knee or osteotomy surgery.
  • Presence of metal-work
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03419598
Other Study ID Numbers  ICMJE RG433_TVT003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Virtual cohort may be re-used for further studies, all virtual patients are anonymized
Responsible Party Richie Gill, University of Bath
Study Sponsor  ICMJE University of Bath
Collaborators  ICMJE Royal Devon and Exeter NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Richie Gill, DPhil University of Bath
Principal Investigator: Andrew Toms, MD Royal Devon & Exeter NHS Trust
PRS Account University of Bath
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP