Unicompartmental Medial Knee OsteoarthritisTOKANCT04574570
TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation
A study testing High Tibial Osteotomy in people with Unicompartmental Medial Knee Osteoarthritis, run by 3D Metal Printing Ltd at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Unicompartmental Medial Knee Osteoarthritis
- What is being tested?
- High Tibial Osteotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 14 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
Study Objectives::
- to assess the morphology of the knee joint and the improvement of OA following the TOKA® treatment.
- to Assess the functional outcome of the knee joint and the improvement of OA following the TOKA® treatment.
Outcomes Evaluations::
- 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.
- 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... .
- Being tested
- High Tibial Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Tibial OsteotomyDevice
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
| Study group | Role | What they receive |
|---|---|---|
| interventional patient | Other | Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) Receives: Device: High Tibial Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months after surgery
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.
Measured: At 6 months after surgery
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.
Measured: At 6 months after surgery
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.
Measured: At 6 months after surgery
Secondary outcomes (10)
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)..
Measured: Before surgery
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).
Measured: Before surgery
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.
Measured: 6 months after surgery.
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).
Measured: 6 months after surgery.
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.
Measured: 6 month after surgery.
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.
Measured: 6 months after surgery.
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)
Measured: 6 months after surgery.
The Functional Assessment Via X-ray Examinations
The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..
Measured: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
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)..
Measured: 6 months after surgery
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).
Measured: at 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start14 Sep 2020
- Primary completion31 May 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Unicompartmental Medial Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3D Metal Printing Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bath
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574570
- Sponsor's protocol ID
- CE-AVEC 623/2019 DISP/IOR TOKA
- Acronym
- TOKA
- Status last verified
- Feb 2024
- First submitted
- 10 Sep 2020
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 18450624Bedson 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 18764949Elson 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 24584646Ren 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 30861539Harris 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 23477914Kallala 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 25628282KELLGREN 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 13498604Konopka 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 25995491Niinimaki 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 23109632Smith 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 26520646Verra 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 26759152Zaffagnini 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 37562120Ruggeri 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 at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluations of the TOKA Customized Device for High Tibial Osteotomy in the Treatment of Knee Osteoarthritis: a Pilot Study.
- ClinicalTrials.gov ID
- NCT04574570
- Acronym / sponsor ID
- TOKA / CE-AVEC 623/2019 DISP/IOR TOKA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- 3D Metal Printing LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Bath
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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::
- to assess the morphology of the knee joint and the improvement of OA following the TOKA® treatment.
- to Assess the functional outcome of the knee joint and the improvement of OA following the TOKA® treatment.
Outcomes Evaluations::
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional patient | Other | Device: High Tibial OsteotomyPersonalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Tibial OsteotomyPersonalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) | Device | interventional patient |
Primary outcome
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.
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.
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.
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.
10 secondary outcomes
Functional Assessment Via Gait Analysis - Kinematics
Time frame: Before surgery
Functional Assessment Via Gait Analysis - Kinetics
Time frame: Before surgery
Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score
Time frame: 6 months after surgery.
Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire
Time frame: 6 months after surgery.
Functional Assessment Via Clinical Scoring - Tegner Score
Time frame: 6 month after surgery.
Functional Assessment Via Clinical Scoring - Knee Society System Score
Time frame: 6 months after surgery.
Functional Assessment Via Clinical Scoring - Visual Analogue Scale
Time frame: 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.
Functional Assessment Via Gait Analysis - Kinematics
Time frame: 6 months after surgery
Functional Assessment Via Gait Analysis - Kinetics
Time frame: at 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18450624Akizuki 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.
- Background: PubMed 18764949Bedson 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.
- Background: PubMed 24584646Elson 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.
- Background: PubMed 30861539Ren 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.
- Background: PubMed 23477914Harris 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.
- Background: PubMed 25628282Kallala 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.
- Background: PubMed 13498604KELLGREN 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.
- Background: PubMed 25995491Konopka 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.
- Background: PubMed 23109632Niinimaki 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.
- Background: PubMed 26520646Smith 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.
- Background: PubMed 26759152Verra 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.
- Derived from this study: PubMed 37562120Zaffagnini 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Tibial Osteotomy in people with Unicompartmental Medial Knee Osteoarthritis, run by 3D Metal Printing Ltd at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphology Assessment Via Correction Angle Assessment (time frame: At 6 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574570, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.