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
Launched by INTEGRUM · Dec 20, 2024
Trial Information
Current as of June 28, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and effectiveness of a special implant system called the OPRA™ Implant System for people who have lost part of their upper arm (transhumeral amputees). The goal is to gather information over a long period, from 6 months to more than 20 years, to see how well the implant performs and how safe it is for patients.
To be eligible for this study, participants must have had an OPRA™ implant placed and completed a specific follow-up visit before January 1, 2024. They should also have at least 6 months of follow-up information after their implant before joining the study. The trial is open to anyone with a unilateral (one side) or bilateral (both sides) arm amputation. During the study, participants will provide clinical data about their experiences with the implant, helping researchers understand its long-term performance and safety.
Gender
ALL
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.
About Integrum
Integrum is a leading clinical trial sponsor dedicated to advancing medical research and innovation across various therapeutic areas. With a commitment to improving patient outcomes, Integrum specializes in the design, execution, and management of clinical trials, leveraging cutting-edge technologies and a robust network of healthcare professionals. The organization emphasizes collaboration and transparency, ensuring that all stakeholders are engaged throughout the research process. By prioritizing ethical standards and regulatory compliance, Integrum strives to deliver high-quality data that informs clinical practice and drives the development of new therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hannover, , Germany
Melbourne, Victoria, Australia
Aarhus, , Denmark
Groningen, , Netherlands
Vienna, , Austria
Ghent, , Belgium
Tübingen, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported