Skip to main content
OpenTrials
Completed

NCT Number: NCT04574570

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

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...

.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Unicompartmental Medial Knee Osteoarthritis

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

High Tibial Osteotomy

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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)..

  2. 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).

  3. 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.

  4. 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).

  5. 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. 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.

  7. 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)

  8. 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..

  9. 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)..

  10. 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).

Sponsors and collaborators

Lead sponsor

3D Metal Printing Ltd

Industry

Collaborators

  • University of Bath

Registry information

Official study title

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

Acronym: TOKA

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.