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ACTIVE NOT RECRUITING
NCT04666571
NA

Personalised Against Standard High Tibial Osteotomy

Sponsor: University of Bath

View on ClinicalTrials.gov

Summary

A study to compare the accuracy of achieving the planned correction between personalised (TOKA) high tibial osteotomy (HTO) procedure and standard generic HTO procedure.

Official title: Personalised Against Standard High Tibial Osteotomy, a Prospective Multi-centre Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2021-07-01

Completion Date

2025-06-29

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

DEVICE

TOKA

The device is a digitally planned (using individual CT scan measured anatomic data) personalised opening wedge high tibial osteotomy (HTO) procedure using a custom 3D printed surgical guide and plate.

DEVICE

Tomofix or ActivMotion

The comparators, Tomofix and ActivMotion, are the most widely used devices for HTO procedures in the UK. Surgical procedures using the Tomofix and ActiveMotion are similar to TOKA, however, they are not patient specific and do not use custom-made plates.

Locations (7)

Royal United Hospitals NHS Trust

Bath, Avon, United Kingdom

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, United Kingdom

Cardiff and Vale University Health Board

Cardiff, Wales, United Kingdom

Royal Orthopaedic Hospital

Birmingham, West Midlands, United Kingdom

Walsall Manor Hospital

Walsall, West Midlands, United Kingdom

Great Western Hospital

Swindon, Wiltshire, United Kingdom

Royal Devon and Exeter NHS Foundation Trust

Exeter, United Kingdom