TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation

Not Applicable

Completed

Conditions: Unicompartmental Medial Knee Osteoarthritis

Registration Number: NCT04574570

Lead Sponsor: 3D Metal Printing Ltd

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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Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functional Assessment Via Gait Analysis - Kinematics	6 months after surgery	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)..
Functional Assessment Via Gait Analysis - Kinetics	at 6 months after surgery	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).
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).
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 - 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 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)

Trial Locations

Locations (1): IRCCS Istituto Ortopedico Rizzoli
🇮🇹
Bologna, Italy
IRCCS Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
Stefano Zaffagnini, Professor
Contact
+390516366075
stefano.zaffagnini@ior.it