Unicompartmental Medial Knee Osteoarthritis
Conditions
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... .
Interventions
DEVICEHigh Tibial Osteotomy
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Sponsors
University of Bath
3D Metal Printing Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphology Assessment Via Correction Angle Assessment | At 6 months after surgery | 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. |
| Morphology Assessment Via Hip-knee-ankle Angle Assessment | At 6 months after surgery | 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. |
| Morphology Assessment Via Mikulicz Point Assessment | At 6 months after surgery | 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. |
| Morphology Assessment Via Posterior Slope Assessment | At 6 months after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment Via Clinical Scoring - Tegner Score | 6 month after surgery. | 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. |
| Functional Assessment Via Clinical Scoring - Knee Society System Score | 6 months after surgery. | 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. |
| Functional Assessment Via Gait Analysis - Kinematics | Before surgery | 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).. |
| The Functional Assessment Via X-ray Examinations | Before surgery and at 1, 3, 6, 12 and 24 months after surgery. | The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees.. |
| Functional Assessment Via Clinical Scoring - Visual Analogue Scale | 6 months after surgery. | 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) |
| Functional Assessment Via Gait Analysis - Kinetics | Before surgery | 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). |
| Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score | 6 months after surgery. | 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. |
| Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire | 6 months after surgery. | 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). |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional Patient Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Interventional Patient |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 7.4 |
| Body Mass Index | 26.8 kg/m2 STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
Population: Operated Patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Morphology Assessment Via Correction Angle Assessment | 1.5 Degree | Standard Deviation 2 |
Primary
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
Population: Operated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Morphology Assessment Via Hip-knee-ankle Angle Assessment | 1.5 Degree | Standard Deviation 2 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Morphology Assessment Via Mikulicz Point Assessment | -9.7 % of medial-lateral tibial plateau width | Standard Deviation 8.4 |
Primary
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
Population: Operated patiemts
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Morphology Assessment Via Posterior Slope Assessment | 0.1 Degree | Standard Deviation 0.3 |
Secondary
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.
Population: Operated patients - European Quality of life via 5-Dimensions questionnaire (total) at 6 month after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire | 7.5 units on scale | Standard Deviation 0.9 |
Secondary
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.
Population: Operated patients - KOOS (total) at 6 month after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score | 81.2 score on a scale | Standard Deviation 9.7 |
Secondary
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.
Population: Operated patients - KSS (total) at 6 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Clinical Scoring - Knee Society System Score | 93.5 score on a scale | Standard Deviation 13.7 |
Secondary
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.
Population: Pot operative patients at 6 month after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Clinical Scoring - Tegner Score | 4.2 score on a scale | Standard Deviation 1.3 |
Secondary
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.
Population: Operated patients - VAS at 6 month after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Clinical Scoring - Visual Analogue Scale | 1.3 score on a scale | Standard Deviation 1 |
Secondary
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
Population: Operated Patients - Max Knee Flexion Rotation at 6 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Gait Analysis - Kinematics | 58 Degree | Standard Deviation 6 |
Secondary
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
Population: Operated Patients - Max Knee Flexion Rotation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Gait Analysis - Kinematics | 70.5 Degree | Standard Deviation 5 |
Secondary
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
Population: Operated Patients - Max Abduction Moment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Gait Analysis - Kinetics | 2.8 % of Body Weight * height | Standard Deviation 0.8 |
Secondary
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
Population: Operated Patients - Max Abduction Moment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | Functional Assessment Via Gait Analysis - Kinetics | 3.8 % of Body Weight * height | Standard Deviation 1.2 |
Secondary
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.
Population: Operated patients at 6 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Patient | The Functional Assessment Via X-ray Examinations | 181.9 Degree | Standard Deviation 2.6 |