TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation (NCT04574570) | Clinical Trial Compass
CompletedNot Applicable
TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation
Italy25 participantsStarted 2020-09-14
Plain-language 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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Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 repla…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Morphology Assessment Via Correction Angle Assessment
Timeframe: At 6 months after surgery
2
Morphology Assessment Via Hip-knee-ankle Angle Assessment
Timeframe: At 6 months after surgery
3
Morphology Assessment Via Mikulicz Point Assessment
Timeframe: At 6 months after surgery
4
Morphology Assessment Via Posterior Slope Assessment