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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
Sponsor:
Collaborator:
Royal Devon and Exeter NHS Foundation Trust
Information provided by (Responsible Party):
Richie Gill, University of Bath

Study Type Observational
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
Hide Arm/Group Description

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
Arm/Group Title All Study Participants
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  35.7%
>=65 years
18
  64.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
67.7  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
15
  53.6%
Male
13
  46.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 28 participants
28
Height (m)  
Mean (Standard Deviation)
Unit of measure:  Metres
Number Analyzed 28 participants
1.686  (0.124)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 28 participants
90.1  (16.4)
Kellgren & Lawrence OA Grade   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
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.

1.Primary Outcome
Title Mechanical Stress in Plate During Gait
Hide Description Mechanical stress (Von Mises) calculated for functional loading using finite element analysis
Time Frame 6 weeks simulated post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Personalised HTO Generic HTO
Hide Arm/Group Description:

Opening wedge high tibial osteotomy

Personalised subject specific custom HTO plate

Opening wedge high tibial osteotomy: Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia

Stabilised by personalised HTO plate, contoured to subject's tibial geometry

Opening wedge high tibial osteotomy

Generic HTO plate

Opening wedge high tibial osteotomy: Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia

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

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: MPa
108.3  (3.81) 90.6  (3.56)
2.Secondary Outcome
Title Mechanical Strain in Bone Around Screws During Gait
Hide Description Mechanical strain calculated for functional loading using finite element analysis, note strain is dimensionless and hence has no units
Time Frame 6 weeks simulated post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Personalised HTO Generic HTO
Hide Arm/Group Description:

Opening wedge high tibial osteotomy

Personalised subject specific custom HTO plate

Opening wedge high tibial osteotomy: Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia

Stabilising by personalised HTO contoured to subject's tibial geometry

Opening wedge high tibial osteotomy

Generic HTO plate

Opening wedge high tibial osteotomy: Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia

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

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: unitless
0.011  (0.00056) 0.011  (0.00065)
Time Frame Adverse Events were not monitored/assessed
Adverse Event Reporting Description Adverse Events were not monitored/assessed
 
Arm/Group Title All Study Participants
Hide Arm/Group Description

Opening wedge high tibial osteotomy (HTO): Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia.

Virtual cohort duplicated into A. stabilised by Personalised HTO plate and B. stabilised by Generic HTO plate.

All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/0 
The main failure mode of HTO plates is fatigue failure, if the peak stress is below the fatigue limit the risk of fatigue failure is low.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Richie Gill
Organization: University of Bath
Phone: 01225 383627
EMail: r.gill@bath.ac.uk
Layout table for additonal information
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