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TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation

NCT04574570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-03

Study results available
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Summary

This preliminary pilot study is a single-centre, prospective, uncontrolled, 32-month study to assess the performance of personalised opening wedge High Tibial Osteotomy (HTO) treatment using the TOKA® device and procedure.

The medical device being examined is a custom-made device and therefore does not require a CE mark. Furthermore, the study will serve as a useful method of gathering clinical data and measuring device performance, as well as establishing a potential commercial relationship with the hospital administration.

Study Objectives::

1. to assess the morphology of the knee joint and the improvement of OA following the TOKA® treatment.
2. to Assess the functional outcome of the knee joint and the improvement of OA following the TOKA® treatment.

Outcomes Evaluations::

1. The morphology of the knee joint is assessed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the correction angle, hip-knee-ankle angle (HKA - mechanical axis), Mikulicz point (recorded as a percentage of the tibial width from the medial to the lateral region) and posterior slope, using the imaging techniques.
2. The functional outcome of the knee joint is assessed by a) performing a gait analysis of the patients pre-operatively and post-operatively, b) the use of clinical scoring...

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Conditions

  • Unicompartmental Medial Knee Osteoarthritis

Interventions

DEVICE

High Tibial Osteotomy

Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)

Sponsors & Collaborators

  • University of Bath

    collaborator OTHER

  • 3D Metal Printing Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-05-31
Completion
2023-12-31

Countries

  • Italy

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 NCT04574570 on ClinicalTrials.gov