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... .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 6 months after surgery
Functional Assessment Via Gait Analysis - Kinematics
The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees)..
Time frame: Before surgery
Functional Assessment Via Gait Analysis - Kinetics
The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinetic results are reported in terms of joint moments (in N\*mm, normalized to patient's body weight times height).
Time frame: Before 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.
Time frame: 6 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 this applied scoring system, respondents rank their health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be rated from 1 to 3 as follows: 1=no problem, 2=moderate problems or 3=severe problems. The final total score is the sum of the scores given to each dimension and ranges from 5 (best outcome) to 15 (worst outcome).
Time frame: 6 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.
Time frame: 6 month 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.
Time frame: 6 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. The score is from 0 to 10 (0= no pain, 10= worst pain ever)
Time frame: 6 months after surgery.
The Functional Assessment Via X-ray Examinations
The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..
Time frame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
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)..
Time frame: 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).
Time frame: at 6 months after surgery
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