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Personalised Against Standard High Tibial Osteotomy

NCT04666571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Medial Knee Osteoarthritis

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.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • 3D Metal Printing Ltd

    collaborator INDUSTRY

  • Versus Arthritis

    collaborator OTHER

  • University of Bath

    lead OTHER

Principal Investigators

  • Richie Gill, Prof · University of Bath

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2024-12-06
Completion
2025-07-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04666571 on ClinicalTrials.gov