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ToKa HTO Versus Generic HTO Virtual Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Opening wedge high tibial osteotomy Device: ToKa subject specific custom HTO plate Device: Generic HTO plate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: ToKa Subject Specific HTO Versus Generic HTO Virtual Clinical Trial
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: ToKa HTO

Opening wedge high tibial osteotomy

ToKa subject specific custom HTO plate

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

Active Comparator: Generic HTO

Opening wedge high tibial osteotomy

Generic HTO plate

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: Generic HTO plate
Generic plate for stabilizing an open wedge HTO
Other Name: Generic plate




Primary Outcome Measures :
  1. Mechanical stress in plate [ Time Frame: 6 weeks simulated post-operation ]
    Mechanical strain calculated for functional loading using finite element analysis


Secondary Outcome Measures :
  1. Mechanical strain in bone around screws [ Time Frame: 6 weeks simulated post-operation ]
    Mechanical strain calculated for functional loading using finite element analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419598


Locations
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United Kingdom
Royal Devon & Exeter NHS Trust
Exeter, Devon, United Kingdom, EX2 5DW
University of Bath
Bath, United Kingdom, BA2 7AY
Sponsors and Collaborators
University of Bath
Royal Devon and Exeter NHS Foundation Trust
Investigators
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Principal Investigator: Richie Gill, DPhil University of Bath
Principal Investigator: Andrew Toms, MD Royal Devon & Exeter NHS Trust
  Study Documents (Full-Text)

Documents provided by Richie Gill, University of Bath:
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Responsible Party: Richie Gill, Professor, University of Bath
ClinicalTrials.gov Identifier: NCT03419598    
Other Study ID Numbers: RG433_TVT003
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Virtual cohort may be re-used for further studies, all virtual patients are anonymized

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richie Gill, University of Bath:
virtual clinical trial
high tibial osteotomy
3D
computer simulation
finite element analysis
medial unicompartmental knee osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases