Trial Outcomes & Findings for Personalised HTO Versus Generic HTO Virtual Clinical Trial (NCT NCT03419598)

NCT ID: NCT03419598

Last Updated: 2020-12-07

Results Overview

Mechanical stress (Von Mises) calculated for functional loading using finite element analysis

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: 6 weeks simulated post-operation
• Results posted on: 2020-12-07

Participant Flow

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.

Participant milestones

Measure	All Study Participants 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.
Overall Study STARTED	30
Overall Study Subject Specific Tibia Models Created and Virtual Osteotomy Performed	28
Overall Study Virtual Cohort Duplicated Into A. Personalised and B. Generic Copies	28
Overall Study Finite Element (FE) Model Created for Cohort Copy Stabilised by Personalised HTO Plate	28
Overall Study FE Models Created for Cohort Copy Stabilised by Generic HTO Plate	28
Overall Study FE Models Solved for Personalised HTO Plate Stabilised Cohort Copy	28
Overall Study FE Models Solved for Generic HTO Plate Stabilised Cohort Copy	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	All Study Participants 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.
Overall Study Poor quality CT scans could not be adequately segmented to create virtual patient tibial geometry	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=28 Participants 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.
Age, Categorical <=18 years	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=28 Participants
Age, Categorical >=65 years	18 Participants n=28 Participants
Age, Continuous	67.7 years STANDARD_DEVIATION 9.0 • n=28 Participants
Sex: Female, Male Female	15 Participants n=28 Participants
Sex: Female, Male Male	13 Participants n=28 Participants
Region of Enrollment United Kingdom	28 participants n=28 Participants
Height (m)	1.686 metres STANDARD_DEVIATION 0.124 • n=28 Participants
Weight (kg)	90.1 kg STANDARD_DEVIATION 16.4 • n=28 Participants
Kellgren & Lawrence OA Grade	2.6 units on a scale STANDARD_DEVIATION 0.9 • n=28 Participants

PRIMARY outcome

Timeframe: 6 weeks simulated post-operation

Mechanical stress (Von Mises) calculated for functional loading using finite element analysis

Outcome measures

Measure	Personalised HTO n=28 Participants 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	Generic HTO n=28 Participants 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
Mechanical Stress in Plate During Gait	108.3 MPa Standard Error 3.81	90.6 MPa Standard Error 3.56

SECONDARY outcome

Timeframe: 6 weeks simulated post-operation

Mechanical strain calculated for functional loading using finite element analysis, note strain is dimensionless and hence has no units

Outcome measures

Measure	Personalised HTO n=28 Participants 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	Generic HTO n=28 Participants 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
Mechanical Strain in Bone Around Screws During Gait	0.011 unitless Standard Error 0.00056	0.011 unitless Standard Error 0.00065

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Richie Gill

University of Bath

Phone: 01225 383627

Email: r.gill@bath.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place