Long-term follow-up of the OPRA Implant System for upper limb amputees
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
Run by Integrum · NCT06753110 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Integrum Industry-sponsored |
| Locations | 6 sites (Melbourne, Victoria and 5 other locations) |
| Status | Recruiting |
| Started | February 19, 2025 |
| Main results expected | December 2025 |
| Study ends | March 2026 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT06753110 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with unilateral or bilateral upper limb amputations who have received the OPRA™ implant system before January 1, 2024.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on osseoanchored prostheses, this specific long-term follow-up approach is relatively novel and untested.
Who can join: the full rules
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 it's running
-
Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
Vienna, Austria Recruiting -
The Alfred Hospital
Melbourne, Victoria, Australia Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Sensorimotor Reorganization After Upper Limb Amputation to Help Protheses
This study tests whether tapping into induced sensations and phantom movements can improve how people control and feel their prosthetic arm.
-
Tracking nerve-freezing during limb amputation to learn about post-operative and phantom limb pain
This registry will track how freezing nerves (cryoablation) is used during limb amputations to see if it affects post-operative and phantom limb pain in adults who have or will have an amputation.
-
People with upper-limb amputation try the TASKA GEN2 multi-grip bionic hand and compare it with other popular prostheses
Adults with upper-limb amputation test the TASKA GEN2 hand to see if it improves daily function and comfort compared with their current prosthesis.
-
Optimize how you control a powered upper-limb prosthesis
This study tests new electrode configurations to improve myoelectric control for people with a below-elbow amputation using a prosthetic arm.
-
Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation
This study tests how the median nerve encodes touch and whether artificial sensory information can be restored in healthy people and people with upper-limb amputations.
-
Relationship between how much of the arm is missing and balance, neck/back pain, daily activities, and reaction time in people with a unilateral upper limb amputation
This study will see if the amount of arm loss relates to balance, neck and back pain, daily tasks, hand dexterity, and reaction time in adults who use a myoelectric or bionic prosthesis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.