Long-term follow-up of the OPRA Implant System for upper limb amputees
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
This study is testing how well the OPRA Implant System works and its safety for people who have lost their upper arm, by following them for many years after their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Sex | All |
| Sponsor | Integrum Industry-sponsored |
| Locations | 6 sites (Melbourne, Victoria and 5 other locations) |
| Trial ID | NCT06753110 on ClinicalTrials.gov |
What this trial studies
This clinical investigation focuses on the long-term safety and efficacy of the OPRA™ Implant System used for transhumeral amputees. It is a multicenter, multinational, cohort study that will collect clinical data over a follow-up period ranging from 6 months to over 20 years. Participants will have been treated with the OPRA™ system prior to January 1, 2024, and will undergo assessments including patient-reported outcomes and functional tests, which can be completed in person or remotely. The study does not include a control group and aims to evaluate the performance of the implant in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are individuals with unilateral or bilateral upper limb amputations who have received the OPRA™ implant system before January 1, 2024.
Not a fit: Patients who have not consented to participate or those implanted with the e-OPRA system at the humeral level will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the OPRA™ Implant System, improving rehabilitation options for amputees.
How similar studies have performed: While there have been studies on osseoanchored prostheses, this specific long-term follow-up approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Melbourne, Victoria and 5 other locations
- The Alfred Hospital — Melbourne, Victoria, Australia (Not_yet_recruiting)
- Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA — Vienna, Austria (Recruiting)
- University Hospital Ghent, UX Ghent — Ghent, Belgium (Not_yet_recruiting)
- Hannover Medical School — Hanover, Germany (Not_yet_recruiting)
- University Hospital Tübing — Tübingen, Germany (Not_yet_recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Chief Medical Officer, MD
- Email: karin.ganlov@integrum.se
- Phone: +46 706753499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.