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CompletedNCT04574570TOKAUpdated Aug 3, 2025Results posted

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

An interventional study of High Tibial Osteotomy in Unicompartmental Medial Knee Osteoarthritis, sponsored by 3D Metal Printing Ltd. Completed at 1 site in Italy. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by 3D Metal Printing Ltd · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
40 Years to 65 Years
Sex
All
01

Study 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...

    .

02

Conditions studied

  • Unicompartmental Medial Knee Osteoarthritis
03

In context

Lead sponsor

This is the only study on the registry with 3D Metal Printing Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    interventional patient

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

    Device: High Tibial Osteotomy

Interventions

  • DeviceHigh Tibial Osteotomy

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

06

What researchers measure

Primary outcomes

  1. Morphology Assessment Via Correction Angle Assessment

    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.

    Time frame: At 6 months after surgery

  2. Morphology Assessment Via Hip-knee-ankle Angle Assessment

    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.

    Time frame: At 6 months after surgery

  3. Morphology Assessment Via Mikulicz Point Assessment

    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.

    Time frame: At 6 months after surgery

  4. Morphology Assessment Via Posterior Slope Assessment

    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.

    Time frame: At 6 months after surgery

Secondary outcomes

  1. Functional Assessment Via Gait Analysis - Kinematics

    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)..

    Time frame: Before surgery

  2. Functional Assessment Via Gait Analysis - Kinetics

    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).

    Time frame: Before surgery

  3. Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score

    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.

    Time frame: 6 months after surgery.

  4. Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire

    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).

    Time frame: 6 months after surgery.

  5. Functional Assessment Via Clinical Scoring - Tegner Score

    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.

    Time frame: 6 month after surgery.

  6. Functional Assessment Via Clinical Scoring - Knee Society System Score

    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.

    Time frame: 6 months after surgery.

  7. Functional Assessment Via Clinical Scoring - Visual Analogue Scale

    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)

    Time frame: 6 months after surgery.

  8. The Functional Assessment Via X-ray Examinations

    The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..

    Time frame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.

  9. Functional Assessment Via Gait Analysis - Kinematics

    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)..

    Time frame: 6 months after surgery

  10. Functional Assessment Via Gait Analysis - Kinetics

    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).

    Time frame: at 6 months after surgery

07

Results

Posted Jul 24, 2025

Participant flow

Participant flow — Overall Study
MilestoneInterventional Patient
Started25
Completed25
Not completed0

Outcome measures

PrimaryMorphology Assessment Via Correction Angle Assessment

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.

Time frame:
At 6 months after surgery
Reported as:
Mean · Degree
Morphology Assessment Via Correction Angle Assessment
DegreeInterventional Patient
Morphology Assessment Via Correction Angle Assessment1.5 ± 2.0
PrimaryMorphology Assessment Via Hip-knee-ankle Angle Assessment

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.

Time frame:
At 6 months after surgery
Reported as:
Mean · Degree
Morphology Assessment Via Hip-knee-ankle Angle Assessment
DegreeInterventional Patient
Morphology Assessment Via Hip-knee-ankle Angle Assessment1.5 ± 2.0
PrimaryMorphology Assessment Via Mikulicz Point Assessment

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.

Time frame:
At 6 months after surgery
Reported as:
Mean · % of medial-lateral tibial plateau width
Morphology Assessment Via Mikulicz Point Assessment
% of medial-lateral tibial plateau widthInterventional Patient
Morphology Assessment Via Mikulicz Point Assessment-9.7 ± 8.4
PrimaryMorphology Assessment Via Posterior Slope Assessment

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.

Time frame:
At 6 months after surgery
Reported as:
Mean · Degree
Morphology Assessment Via Posterior Slope Assessment
DegreeInterventional Patient
Morphology Assessment Via Posterior Slope Assessment0.1 ± 0.3
SecondaryFunctional Assessment Via Gait Analysis - Kinematics

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)..

Time frame:
Before surgery
Reported as:
Mean · Degree
Functional Assessment Via Gait Analysis - Kinematics
DegreeInterventional Patient
Functional Assessment Via Gait Analysis - Kinematics70.5 ± 5.0
SecondaryFunctional Assessment Via Gait Analysis - Kinetics

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).

Time frame:
Before surgery
Reported as:
Mean · % of Body Weight * height
Functional Assessment Via Gait Analysis - Kinetics
% of Body Weight * heightInterventional Patient
Functional Assessment Via Gait Analysis - Kinetics3.8 ± 1.2
SecondaryFunctional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score

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.

Time frame:
6 months after surgery.
Reported as:
Mean · score on a scale
Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score
score on a scaleInterventional Patient
Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score81.2 ± 9.7
SecondaryFunctional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire

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).

Time frame:
6 months after surgery.
Reported as:
Mean · units on scale
Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire
units on scaleInterventional Patient
Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire7.5 ± 0.9
SecondaryFunctional Assessment Via Clinical Scoring - Tegner Score

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.

Time frame:
6 month after surgery.
Reported as:
Mean · score on a scale
Functional Assessment Via Clinical Scoring - Tegner Score
score on a scaleInterventional Patient
Functional Assessment Via Clinical Scoring - Tegner Score4.2 ± 1.3
SecondaryFunctional Assessment Via Clinical Scoring - Knee Society System Score

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.

Time frame:
6 months after surgery.
Reported as:
Mean · score on a scale
Functional Assessment Via Clinical Scoring - Knee Society System Score
score on a scaleInterventional Patient
Functional Assessment Via Clinical Scoring - Knee Society System Score93.5 ± 13.7
SecondaryFunctional Assessment Via Clinical Scoring - Visual Analogue Scale

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)

Time frame:
6 months after surgery.
Reported as:
Mean · score on a scale
Functional Assessment Via Clinical Scoring - Visual Analogue Scale
score on a scaleInterventional Patient
Functional Assessment Via Clinical Scoring - Visual Analogue Scale1.3 ± 1.0
SecondaryThe Functional Assessment Via X-ray Examinations

The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..

Time frame:
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Reported as:
Mean · Degree
The Functional Assessment Via X-ray Examinations
DegreeInterventional Patient
The Functional Assessment Via X-ray Examinations181.9 ± 2.6
SecondaryFunctional Assessment Via Gait Analysis - Kinematics

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)..

Time frame:
6 months after surgery
Reported as:
Mean · Degree
Functional Assessment Via Gait Analysis - Kinematics
DegreeInterventional Patient
Functional Assessment Via Gait Analysis - Kinematics58 ± 6.0
SecondaryFunctional Assessment Via Gait Analysis - Kinetics

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).

Time frame:
at 6 months after surgery
Reported as:
Mean · % of Body Weight * height
Functional Assessment Via Gait Analysis - Kinetics
% of Body Weight * heightInterventional Patient
Functional Assessment Via Gait Analysis - Kinetics2.8 ± 0.8

Adverse events

Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Interventional Patient0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Interventional Patient
Mean54.4 ± 7.4
Sex: Female, Male
Sex: Female, Male(Participants)Interventional Patient
Female6
Male19
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Interventional Patient
Hispanic or Latino0
Not Hispanic or Latino0
Unknown or Not Reported25
Body Mass Index
Body Mass Index(kg/m2)Interventional Patient
Mean26.8 ± 4.0
08

Study locations

1 site
  • IRCCS Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
09

References and documents

Publications

  • Akizuki S, Shibakawa A, Takizawa T, Yamazaki I, Horiuchi H. The long-term outcome of high tibial osteotomy: a ten- to 20-year follow-up. J Bone Joint Surg Br. 2008 May;90(5):592-6. doi: 10.1302/0301-620X.90B5.20386. PubMed 18450624 ↗
  • Bedson J, Croft PR. The discordance between clinical and radiographic knee osteoarthritis: a systematic search and summary of the literature. BMC Musculoskelet Disord. 2008 Sep 2;9:116. doi: 10.1186/1471-2474-9-116. PubMed 18764949 ↗
  • Elson DW, Petheram TG, Dawson MJ. High reliability in digital planning of medial opening wedge high tibial osteotomy, using Miniaci's method. Knee Surg Sports Traumatol Arthrosc. 2015 Jul;23(7):2041-8. doi: 10.1007/s00167-014-2920-x. Epub 2014 Mar 1. PubMed 24584646 ↗
  • Ren YM, Duan YH, Sun YB, Yang T, Hou WY, Zhu RS, Tian MQ. Opening-Wedge High Tibial Osteotomy Using Autograft versus Allograft: A Systematic Review and Meta-analysis. J Knee Surg. 2020 Jun;33(6):565-575. doi: 10.1055/s-0039-1681065. Epub 2019 Mar 12. PubMed 30861539 ↗
  • Harris JD, McNeilan R, Siston RA, Flanigan DC. Survival and clinical outcome of isolated high tibial osteotomy and combined biological knee reconstruction. Knee. 2013 Jun;20(3):154-61. doi: 10.1016/j.knee.2012.12.012. Epub 2013 Mar 9. PubMed 23477914 ↗
  • Kallala RF, Vanhegan IS, Ibrahim MS, Sarmah S, Haddad FS. Financial analysis of revision knee surgery based on NHS tariffs and hospital costs: does it pay to provide a revision service? Bone Joint J. 2015 Feb;97-B(2):197-201. doi: 10.1302/0301-620X.97B2.33707. PubMed 25628282 ↗
  • KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available. PubMed 13498604 ↗
  • Konopka JF, Gomoll AH, Thornhill TS, Katz JN, Losina E. The cost-effectiveness of surgical treatment of medial unicompartmental knee osteoarthritis in younger patients: a computer model-based evaluation. J Bone Joint Surg Am. 2015 May 20;97(10):807-17. doi: 10.2106/JBJS.N.00925. PubMed 25995491 ↗
  • Niinimaki TT, Eskelinen A, Mann BS, Junnila M, Ohtonen P, Leppilahti J. Survivorship of high tibial osteotomy in the treatment of osteoarthritis of the knee: Finnish registry-based study of 3195 knees. J Bone Joint Surg Br. 2012 Nov;94(11):1517-21. doi: 10.1302/0301-620X.94B11.29601. PubMed 23109632 ↗
  • Smith WB 2nd, Steinberg J, Scholtes S, Mcnamara IR. Medial compartment knee osteoarthritis: age-stratified cost-effectiveness of total knee arthroplasty, unicompartmental knee arthroplasty, and high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):924-933. doi: 10.1007/s00167-015-3821-3. Epub 2015 Oct 31. PubMed 26520646 ↗
  • Verra WC, Witteveen KQ, Maier AB, Gademan MG, van der Linden HM, Nelissen RG. The reason why orthopaedic surgeons perform total knee replacement: results of a randomised study using case vignettes. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2697-703. doi: 10.1007/s00167-015-3961-5. Epub 2016 Jan 12. PubMed 26759152 ↗
  • Zaffagnini S, Dal Fabbro G, Lucidi GA, Agostinone P, Belvedere C, Leardini A, Grassi A. Personalised opening wedge high tibial osteotomy with patient-specific plates and instrumentation accurately controls coronal correction and posterior slope: Results from a prospective first case series. Knee. 2023 Oct;44:89-99. doi: 10.1016/j.knee.2023.07.011. Epub 2023 Aug 8. PubMed 37562120 ↗
  • Ruggeri M, Gill HS, Leardini A, Zaffagnini S, MacLeod A, Ortolani M, Faccia F, Grassi A, Fabbro GD, Durante S, Belvedere C. Superimposition of ground reaction force on tibial-plateau supporting diagnostics and post-operative evaluations in high-tibial osteotomy. A novel methodology. Gait Posture. 2022 May;94:144-152. doi: 10.1016/j.gaitpost.2022.02.028. Epub 2022 Feb 25. PubMed 35334334 ↗

Study documents

  • Study protocol · Oct 7, 2019
  • Informed consent form · Oct 7, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04574570
Lead sponsor
3D Metal Printing Ltd
Collaborators
University of Bath
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Sep 14, 2020
Primary completion
May 31, 2021
Completion
Dec 31, 2023
Results posted
Jul 24, 2025
Last update
Aug 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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