Status:
RECRUITING
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
Lead Sponsor:
Integrum
Conditions:
Amputation of Upper Limb
Eligibility:
All Genders
Phase:
NA
Brief 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 \...
Detailed Description
All subjects that will be enrolled in this investigation should have been treated with the OPRA Implant System for a transhumeral unilateral or bilateral amputation and completed the second stage surg...
Eligibility Criteria
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.
Key Trial Info
Start Date :
February 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06753110
Start Date
February 19 2025
End Date
March 1 2026
Last Update
July 3 2025
Active Locations (6)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
2
Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
Vienna, Austria, 1090
3
University Hospital Ghent, UX Ghent
Ghent, Belgium, 9000
4
Hannover Medical School
Hanover, Germany, 30625