N/A
N=25
TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation
Unicompartmental Medial Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04574570 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Morphology Assessment Via Correction Angle Assessment — 1.5 Degree
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Tibial Osteotomy (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- 3D Metal Printing Ltd
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morphology Assessment Via Correction Angle Assessment |
1.5 | — |
| PRIMARY Morphology Assessment Via Hip-knee-ankle Angle Assessment |
1.5 | — |
| PRIMARY Morphology Assessment Via Mikulicz Point Assessment |
-9.7 | — |
| PRIMARY Morphology Assessment Via Posterior Slope Assessment |
0.1 | — |
| SECONDARY Functional Assessment Via Gait Analysis - Kinematics |
58 | — |
| SECONDARY Functional Assessment Via Gait Analysis - Kinetics |
2.8 | — |
| SECONDARY Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score |
81.2 | — |
| SECONDARY Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire |
7.5 | — |
| SECONDARY Functional Assessment Via Clinical Scoring - Tegner Score |
4.2 | — |
| SECONDARY Functional Assessment Via Clinical Scoring - Knee Society System Score |
93.5 | — |
| SECONDARY Functional Assessment Via Clinical Scoring - Visual Analogue Scale |
1.3 | — |
| SECONDARY The Functional Assessment Via X-ray Examinations |
181.9 | — |
| SECONDARY Functional Assessment Via Gait Analysis - Kinematics |
58 | — |
| SECONDARY Functional Assessment Via Gait Analysis - Kinetics |
2.8 | — |
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...
.
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 30 days).
Data sourced from ClinicalTrials.gov (NCT04574570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.