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Personalised Against Standard High Tibial Osteotomy
Sponsor: University of Bath
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
Conditions
Interventions
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.
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