Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 39 for:    HTO

Personalised 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 : Completed
First Posted : February 5, 2018
Results First Posted : December 7, 2020
Last Update Posted : December 7, 2020
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, 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.


Condition or disease Intervention/treatment
Osteoarthritis, Knee Procedure: Opening wedge high tibial osteotomy Device: Personalised subject specific custom HTO plate Device: Generic HTO plate

Detailed Description:

Ethical approval was obtained to use CT scans of 30 patients with moderate to severe knee arthritis (REC reference: 17/HRA/0033, Royal Devon & Exeter National Health Service [NHS], UK).

The CT data will be used to generate the 3D geometry of each patient's proximal tibia. The osteotomy correction angle required for each patient such that the altered mechanical axis will pass through a point 62.5% of the distance from medial to lateral tibial plateau. Virtual HTO surgery will be performed on each patient to alter the mechanical axis of the knee by creating an opening wedge osteotomy.

After the virtual surgeries are performed, each virtual patient will be duplicated. One copy will have the osteotomy stabilised using a Generic plate and the other using a Personalised plate, thus forming the two arms of the trial.

For each participant in each arm finite element (FE) models will be created, and loads applied simulating walking, sit to stand and squatting. Four healings stages will be considered, stage 1 being immediately post-operation (this will not be modelled), stage 2 representing 2 weeks post-operation, stage 3 representing 6 weeks and stage 4 representing 12 weeks. The mechanical loads in the plates, and around the screw locations in the bone, will be established by solving these finite element models.

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Personalised Subject Specific HTO Versus Generic HTO Virtual Clinical Trial
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort Intervention/treatment
All study participants
All virtual participants who received a virtual opening wedge high tibial osteotomy. The baseline information was the individual CT-based geometry of tibia.
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
Other Name: HTO

Device: Personalised subject specific custom HTO plate
Subject specific custom plate for stabilizing an open wedge HTO
Other Name: Personalised plate

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




Primary Outcome Measures :
  1. Mechanical Stress in Plate During Gait [ Time Frame: 6 weeks simulated post-operation ]
    Mechanical stress (Von Mises) calculated for functional loading using finite element analysis


Secondary Outcome Measures :
  1. Mechanical Strain in Bone Around Screws During Gait [ Time Frame: 6 weeks simulated post-operation ]
    Mechanical strain calculated for functional loading using finite element analysis, note strain is dimensionless and hence has no units



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population was recruited from waiting list of patients with knee OA
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
Layout table for location information
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
Layout table for investigator information
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:
Layout table for additonal information
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
Results First Posted: December 7, 2020
Last Update Posted: December 7, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Virtual cohort may be re-used for further studies, all virtual patients are anonymized

Layout table for additional information
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:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases