Onderzoek: armprothese clinical post market study Michelangelo / MyoPlus

Clinical post market study Michelangelo/MyoPlus (PROM); a multinational post-market study on patient reported outcomes of Michelangelo and Myo Plus system (in this case this is Myo Plus and bebionic hand) users. The plan is to start the study in Q3 2021 and finish in Q3 2022. Data collection shall be finished in Q2 2022. Users can be enrolled from Q3 2021 until Q2 2022.

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Onderzoek: armprothese clinical post market study Michelangelo / MyoPlus

Korte omschrijving van het onderzoek

Goal:

Comparison of multi-grip hand with conventional and MyoPlus control. Goal of the study is to collect data of upper limb amputees using the Michelangelo or the Myo Plus system (Myo Plus with bebionic hand). The primary focus is on psychosocial adjustments and quality of life and a secondary focus is on pain and activities of daily living.


Study background:

Contribute to further characterization of responder population. Clinical post market study Michelangelo/MyoPlus (PROM); a multinational post-market study on patient reported outcomes of Michelangelo and Myo Plus system (in this case this is Myo Plus and bebionic hand) users. The plan is to start the study in Q3 2021 and finish in Q3 2022. Data collection shall be finished in Q2 2022. Users can be enrolled from Q3 2021 until Q2 2022.


Study design:

Cross-sectional, multicenter, post-market study. This multinational study plans to enroll up to 115 patients in approximately 30 different sites. No site visits are planned. The participants take part in the study by answering questionnaires. The task of the CPO is to identify suitable patients according to the inclusion and exclusion criteria and to send the questionnaires to the patients. At the moment we are planning to use an electronic survey, thus a link to the patient has to be sent via mail. Patients will give their informed consent before answering the questionnaires.

Results:

Coming soon


Conclusion:

Researchers and other participants: Up to 30 sites in France, Germany, USA, Sweden, Norway, The Netherlands.

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