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

Phase

N/A

Condition

Osteoarthritis

Treatment

High Tibial Osteotomy

Clinical Study ID

NCT04574570

CE-AVEC 623/2019 DISP/IOR TOKA

Ages 40-65
All Genders

Study 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::

to assess the morphology of the knee joint and the improvement of OA following the TOKA® treatment.
to Assess the functional outcome of the knee joint and the improvement of OA following the TOKA® treatment.

Outcomes Evaluations::

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.
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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Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Refusal to consent to the study
Pregnancy
Prisoners
A patient known to have substance abuse or psychological disorders that couldinterfere with their ability to comply with the post-operative rehabilitation andassessment schedules
Patients unable to read or understand the patient information leaflet and consentform
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 kneejoint at time of study device implantation.
Patient has received any orthopaedic surgical intervention to the lower extremitieswithin the past year or is expected to require any orthopaedic surgical interventionto the lower extremities, other than the HTO to be enrolled in this study, withinthe next year.
Patient requires bilateral HTO or has a history of unsuccessful contralateralpartial replacement or HTO.
Patient has chronic heart failure (NYHA Stage ≥ 2)
Patient has a neuromuscular or neurosensory deficiency, which limits the ability toevaluate the safety and efficacy of the device.
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or ametabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normalphysiological requirements (e.g. > 30 days).

Study Design

High Tibial Osteotomy

September 14, 2020

December 31, 2023

Connect with a study center

IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Italy
Site Not Available

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