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

  • STATUS
    Recruiting
  • participants needed
    25
  • sponsor
    3D Metal Printing Ltd
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Updated on 29 January 2023
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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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Details
Condition Unicompartmental Medial Knee Osteoarthritis
Treatment high tibial osteotomy
Clinical Study IdentifierNCT04574570
Sponsor3D Metal Printing Ltd
Last Modified on29 January 2023

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