Personalised HTO Versus Generic HTO Virtual Clinical Trial
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ClinicalTrials.gov Identifier: NCT03419598 |
Recruitment Status :
Completed
First Posted : February 5, 2018
Results First Posted : December 7, 2020
Last Update Posted : December 7, 2020
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Study Type | Observational |
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Study Design | Observational Model: Case-Control; Time Perspective: Prospective |
Condition |
Osteoarthritis, Knee |
Interventions |
Procedure: Opening wedge high tibial osteotomy Device: Personalised subject specific custom HTO plate Device: Generic HTO plate |
Enrollment | 30 |
Recruitment Details | The virtual patients were created based on CT data sets obtained for 30 patients with knee osteoarthritis. The virtual patients were duplicated, and then enrolled into both arms. |
Pre-assignment Details |
Arm/Group Title | All Study Participants |
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Opening wedge high tibial osteotomy (HTO). 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 had the osteotomy stabilised by a generic HTO plate in one copy of the cohort and by a personalised HTO plate in the other copy. |
Period Title: Overall Study | |
Started [1] | 30 |
Subject Specific Tibia Models Created and Virtual Osteotomy Performed | 28 |
Virtual Cohort Duplicated Into A. Personalised and B. Generic Copies | 28 |
Finite Element (FE) Model Created for Cohort Copy Stabilised by Personalised HTO Plate | 28 |
FE Models Created for Cohort Copy Stabilised by Generic HTO Plate | 28 |
FE Models Solved for Personalised HTO Plate Stabilised Cohort Copy | 28 |
FE Models Solved for Generic HTO Plate Stabilised Cohort Copy | 28 |
Completed | 28 |
Not Completed | 2 |
Reason Not Completed | |
Poor quality CT scans could not be adequately segmented to create virtual patient tibial geometry | 2 |
[1]
Since this is a virtual trial, the virtual patients were duplicated and enrolled into both arms
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Arm/Group Title | All Study Participants | |
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Opening wedge high tibial osteotomy (HTO): Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia Cohort duplicated into 2 copies. Copy A. Stabilised by Personalised HTO plate. Copy B. Stabilised by Generic HTO plate. |
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Overall Number of Baseline Participants | 28 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
10 35.7%
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>=65 years |
18 64.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 28 participants | |
67.7 (9.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | |
Female |
15 53.6%
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Male |
13 46.4%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | |
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United Kingdom | Number Analyzed | 28 participants |
28 | ||
Height (m)
Mean (Standard Deviation) Unit of measure: Metres |
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Number Analyzed | 28 participants | |
1.686 (0.124) | ||
Weight (kg)
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 28 participants | |
90.1 (16.4) | ||
Kellgren & Lawrence OA Grade
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 28 participants | |
2.6 (0.9) | ||
[1]
Measure Description:
Radiographic grading scale for osteoarthritis (OA) of a joint. Grade 0 (none): definite absence of x-ray changes of osteoarthritis. Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping. Grade 2 (minimal): definite osteophytes and possible joint space narrowing. Grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends. Grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends. |
Name/Title: | Professor Richie Gill |
Organization: | University of Bath |
Phone: | 01225 383627 |
EMail: | r.gill@bath.ac.uk |
Responsible Party: | Richie Gill, University of Bath |
ClinicalTrials.gov Identifier: | NCT03419598 |
Other Study ID Numbers: |
RG433_TVT003 |
First Submitted: | January 26, 2018 |
First Posted: | February 5, 2018 |
Results First Submitted: | October 5, 2019 |
Results First Posted: | December 7, 2020 |
Last Update Posted: | December 7, 2020 |