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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorIntegrum

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Subject not willing to consent

Subject implanted with the e-OPRA system at the humeral level.

Trial design

Treatments tested in this trial

  • OPRA transhumeral

Treatment groups

70 Participants
are divided into 1 treatment group

Locations

6
Australia
The Alfred Hospital3004, MelbourneVictoria, Australia
Austria
Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA1090, Vienna Austria
Belgium
University Hospital Ghent, UX Ghent9000, Ghent Belgium
Germany
Hannover Medical School30625, Hanover Germany

Sponsors and collaborators

Integrum

Lead sponsor