Clinical trial NCT04574570: TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation
Official title: Clinical Evaluations of the TOKA Customized Device for High Tibial Osteotomy in the Treatment of Knee Osteoarthritis: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unicompartmental Medial Knee Osteoarthritis
Lead sponsor: 3D Metal Printing Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Bath
First posted: 2020-10-05
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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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Eligibility 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).

Primary outcomes:
measure: Morphology Assessment via correction angle assessment
timeFrame: At 6 months after surgery
measure: Morphology Assessment via hip-knee-ankle angle assessment
timeFrame: At 6 months after surgery
measure: Morphology Assessment via Mikulicz point assessment
timeFrame: At 6 months after surgery
measure: Morphology Assessment via posterior slope assessment
timeFrame: At 6 months after surgery
Secondary outcomes:
measure: Functional Assessment via gait analysis - kinematics
timeFrame: Before surgery and at 6 months after surgery
measure: Functional Assessment via gait analysis - kinetics
timeFrame: Before surgery and at 6 months after surgery
measure: Functional Assessment via clinical scoring - Knee Osteoarthritis Outcome Score
timeFrame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
measure: Functional Assessment via clinical scoring - European Quality of life via 5-Dimensions questionnaire
timeFrame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
measure: Functional Assessment via clinical scoring - Tegner score
timeFrame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
measure: Functional Assessment via clinical scoring - Knee Society System Score
timeFrame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
measure: Functional Assessment via clinical scoring - Visual Analogue Scale
timeFrame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
measure: The functional assessment ivia x-ray examinations
timeFrame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
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