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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
Sponsor: Integrum
Summary
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-02-19
Completion Date
2026-03
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
OPRA transhumeral
Skeletal anchorage of amputation prostheses.
Locations (6)
The Alfred Hospital
Melbourne, Victoria, 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