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

NCT04574570 | Completed Results

• 1 other identifier: CE-AVEC 623/2019 DISP/IOR TOKA
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 1.to assess the morphology of the knee joint and the improvement of OA following the TOKA® treatment.
2. 2.to Assess the functional outcome of the knee joint and the improvement of OA following the TOKA® treatment.
3. 3.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.
4. 4.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...

Conditions

Unicompartmental Medial Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At 6 months after surgery

Secondary Outcomes (10)

• Functional Assessment Via Gait Analysis - Kinematics

  Before surgery

• Functional Assessment Via Gait Analysis - Kinetics

  Before surgery

• Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score

  6 months after surgery.

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

  6 months after surgery.

• Functional Assessment Via Clinical Scoring - Tegner Score

  6 month after surgery.

Study Arms (1)

interventional patient

OTHER

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

Device: High Tibial Osteotomy

Interventions

High Tibial Osteotomy DEVICE

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

interventional patient

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• 3D Metal Printing Ltd: lead
• University of Bath: collaborator

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (13)

• 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.

  PMID: 18450624 BACKGROUND

• 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.

  PMID: 18764949 BACKGROUND

• 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.

  PMID: 24584646 BACKGROUND

• 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.

  PMID: 30861539 BACKGROUND

• 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.

  PMID: 23477914 BACKGROUND

• 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.

  PMID: 25628282 BACKGROUND

• 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.

  PMID: 13498604 BACKGROUND

• 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.

  PMID: 25995491 BACKGROUND

• 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.

  PMID: 23109632 BACKGROUND

• 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.

  PMID: 26520646 BACKGROUND

• 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.

  PMID: 26759152 BACKGROUND

• 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.

  PMID: 37562120 DERIVED

• 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.

  PMID: 35334334 DERIVED

Results Point of Contact

• Title: Dr Stefano Zaffagnini
• Organization: IRCCS Istituto Ortopedico Rizzoli

stefano.zaffagnini@unibo.it

+3905163665706366111

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 5, 2020
• Study Start: September 14, 2020
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2023
• Last Updated: August 3, 2025
• Results First Posted: July 24, 2025

Record last verified: 2024-02

Locations

IT (1)