Actively 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
Led by Integrum · Updated on 2025-07-03
70
Participants Needed
6
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral or bilateral amputation
- OPRA implant system placed and second stage surgery completed before 01-Jan-2024
- At least 6 months of follow-up between second stage surgery and enrollment
You will not qualify if you...
- Not willing to provide consent
- Implanted with the e-OPRA system at the humeral level
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
2
Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
Vienna, Austria, 1090
Actively Recruiting
3
University Hospital Ghent, UX Ghent
Ghent, Belgium, 9000
Not Yet Recruiting
4
Hannover Medical School
Hanover, Germany, 30625
Not Yet Recruiting
5
University Hospital Tübing
Tübingen, Germany, 72076
Not Yet Recruiting
6
University Medical Center Groningen
Groningen, Netherlands, 9700
Not Yet Recruiting
Research Team
C
Chief Medical Officer, MD
CONTACT
H
Head of Clinical Operations, M.Sc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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