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A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients

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In plain words

What the trial is, and whether it could suit you

This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to \>20 years in function. It will collect and evaluate clinical data on the safety and performance of the OPRA™ Implant System when used on transhumeral amputees and within the scope of the intended use.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Unilateral or bilateral amputation * OPRA™ implant system placed, and with S2 completed before 01-Jan-2024 * Having a minimum of 6 months of follow-up between S2 and enrolment Exclusion Criteria: * Subject not willing to consent * Subject implanted with the e-OPRA system at the humeral level.
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What it tests

  • OPRA transhumeral
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Where

6 sites
The Alfred Hospital
Melbourne, Australia
Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
Vienna, Austria
University Hospital Ghent, UX Ghent
Ghent, Belgium
Hannover Medical School
Hanover, Germany
University Hospital Tübing
Tübingen, Germany
University Medical Center Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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