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

Study Overview
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Brief Summary
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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... .

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

Conditions
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Unicompartmental Medial Knee Osteoarthritis

Intervention / Treatment
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* Device: High Tibial Osteotomy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: interventional patient<br>Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) | Device: High Tibial Osteotomy<br>* Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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).. | Before surgery and at 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). | Before surgery and at 6 months after 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. | Before surgery and at 1, 3, 6, 12 and 24 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 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. | Before surgery and at 1, 3, 6, 12 and 24 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. | Before surgery and at 1, 3, 6, 12 and 24 months 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. | Before surgery and at 1, 3, 6, 12 and 24 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; 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. | Before surgery and at 1, 3, 6, 12 and 24 months after surgery. | 
| The functional assessment ivia x-ray examinations | The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees.. | Before surgery and at 1, 3, 6, 12 and 24 months after surgery. |