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

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ClinicalTrials.gov Identifier: NCT04574570
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
University of Bath
Information provided by (Responsible Party):
3D Metal Printing Ltd

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. 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...

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Condition or disease Intervention/treatment Phase
Unicompartmental Medial Knee Osteoarthritis Device: High Tibial Osteotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluations of the TOKA Customized Device for High Tibial Osteotomy in the Treatment of Knee Osteoarthritis: a Pilot Study.
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : November 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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®)




Primary Outcome Measures :
  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 Outcome Measures :
  1. Functional Assessment via gait analysis - kinematics [ Time Frame: Before surgery and 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 rotations (in degrees)..

  2. Functional Assessment via gait analysis - kinetics [ Time Frame: Before surgery and 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).

  3. Functional Assessment via clinical scoring - Knee Osteoarthritis Outcome Score [ Time Frame: Before surgery and at 1, 3, 6, 12 and 24 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: Before surgery and at 1, 3, 6, 12 and 24 months after surgery. ]
    The functional assessment is performed via clinical scoring using the European Quality of life via 5-Dimensions questionnaire (EQ-5D). In applied EQ-5D, the respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems. Based on that, patients could be classified into 243 health states and 2 additional states (unconscious and dead). The EQ-5D health states are converted into a single summary score by applying weights to each of the levels in each dimension, as is typically done in cost utility analysis. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.

  5. Functional Assessment via clinical scoring - Tegner score [ Time Frame: Before surgery and at 1, 3, 6, 12 and 24 months 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: Before surgery and at 1, 3, 6, 12 and 24 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: Before surgery and at 1, 3, 6, 12 and 24 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; on this line, patients are asked to mark a point that matches the amount of pain they feel; the quantification of the point location with respect to the two ends is representative of the ammount of pain.

  8. The functional assessment ivia 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..



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574570


Contacts
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Contact: Stefano Zaffagnini, Professor +390516366075 stefano.zaffagnini@ior.it
Contact: Claudio Belvedere, PhD +390516366570 belvedere@ior.it

Locations
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Italy
IRCCS Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Stefano Zaffagnini, Professor    +390516366075    stefano.zaffagnini@ior.it   
Sponsors and Collaborators
3D Metal Printing Ltd
University of Bath
  Study Documents (Full-Text)

Documents provided by 3D Metal Printing Ltd:
Informed Consent Form  [PDF] October 21, 2019

Additional Information:
Publications:

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Responsible Party: 3D Metal Printing Ltd
ClinicalTrials.gov Identifier: NCT04574570    
Other Study ID Numbers: CE-AVEC 623/2019 DISP/IOR TOKA
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases