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

July 24, 2025 updated by: 3D Metal Printing Ltd

Clinical Evaluations of the TOKA Customized Device for High Tibial Osteotomy in the Treatment of Knee Osteoarthritis: a Pilot Study.

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...

    .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing opening wedge Hight Tibial Osteotomy (HTO)
  • Patients must have completed a consent form for the study
  • Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study
  • Patient in whom any varus deformity present is <20°
  • The diagnosis is of unicompartmental medial osteoarthritis of the knee
  • Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
  • BMI<40
  • Age range 40 to 65 years

Exclusion Criteria:

  • Refusal to consent to the study
  • Pregnancy
  • Prisoners
  • A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the post-operative rehabilitation and assessment schedules
  • Patients unable to read or understand the patient information leaflet and consent form
  • Patient has a known sensitivity to device materials.
  • Patient has a Body Mass Index (BMI) ≥ 40.
  • Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
  • Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the HTO to be enrolled in this study, within the next year.
  • Patient requires bilateral HTO or has a history of unsuccessful contralateral partial replacement or HTO.
  • Patient has chronic heart failure (NYHA Stage ≥ 2)
  • Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
  • Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
  • Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: interventional patient
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Device: High Tibial Osteotomy
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphology Assessment Via Correction Angle Assessment
Time Frame: At 6 months after surgery
The device morphology assessment is performed 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, using image-based techniques.
At 6 months after surgery
Morphology Assessment Via Hip-knee-ankle Angle Assessment
Time Frame: At 6 months after surgery
The device morphology assessment is performed 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 hip-knee-ankle angle (HKA - mechanical axis) reported in degree, using image-based techniques.
At 6 months after surgery
Morphology Assessment Via Mikulicz Point Assessment
Time Frame: At 6 months after surgery
The device morphology assessment is performed 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 Mikulicz point reported in % of the tibial width from the medial to the lateral region, using image-based techniques.
At 6 months after surgery
Morphology Assessment Via Posterior Slope Assessment
Time Frame: At 6 months after surgery
The device morphology assessment is performed 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 posterior slope reported in degree, using image-based techniques.
At 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment Via Gait Analysis - Kinematics
Time Frame: Before surgery
The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees)..
Before surgery
Functional Assessment Via Gait Analysis - Kinetics
Time Frame: Before surgery
The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinetic results are reported in terms of joint moments (in N*mm, normalized to patient's body weight times height).
Before surgery
Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score
Time Frame: 6 months after surgery.
The functional assessment is performed via clinical scoring using the Knee Osteoarthritis Outcome Score (KOOS). KOOS value range: [min / max]= 0 - 100, higher values mean better outcome.
6 months after surgery.
Functional Assessment Via Clinical Scoring - Tegner Score
Time Frame: 6 month after surgery.
The functional assessment is performed via clinical scoring using the Tegner score. Tegner scale value range: [min / max]= 0 - 10, higher values mean better outcome.
6 month after surgery.
Functional Assessment Via Clinical Scoring - Knee Society System Score
Time Frame: 6 months after surgery.
The functional assessment is performed via clinical scoring using the knee society system score (KSS). KSS value range: [min / max]= 0 - 100, higher values mean better outcome.
6 months after surgery.
Functional Assessment Via Clinical Scoring - Visual Analogue Scale
Time Frame: 6 months after surgery.

The functional assessment is performed via clinical scoring using the Visual Analogue Scale (VAS). VAS is based on a 10-cm long straight line with one end meaning no pain and the other end meaning the worst pain.

The score is from 0 to 10 (0= no pain, 10= worst pain ever)
6 months after surgery.
The Functional Assessment Via X-ray Examinations
Time Frame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Functional Assessment Via Gait Analysis - Kinematics
Time Frame: 6 months after surgery
The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees)..
6 months after surgery
Functional Assessment Via Gait Analysis - Kinetics
Time Frame: at 6 months after surgery
The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint moments (in N*mm, normalized to patient's body weight times height).
at 6 months after surgery
Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire
Time Frame: 6 months after surgery.

The functional assessment is performed via clinical scoring using the European Quality of life via 5-Dimensions questionnaire (EQ-5D). In this applied scoring system, respondents rank their health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be rated from 1 to 3 as follows: 1=no problem, 2=moderate problems or 3=severe problems.

The final total score is the sum of the scores given to each dimension and ranges from 5 (best outcome) to 15 (worst outcome).
6 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3D Metal Printing Ltd

Collaborators

University of Bath

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-AVEC 623/2019 DISP/IOR TOKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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