RecruitingNot ApplicableNCT06753110
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
Sponsor
Integrum
Enrollment
70 participants
Start Date
Feb 19, 2025
Study Type
INTERVENTIONAL
Conditions
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 \>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.
Eligibility
Inclusion Criteria3
- 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 Criteria2
- Subject not willing to consent
- Subject implanted with the e-OPRA system at the humeral level.
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Interventions
DEVICEOPRA transhumeral
Skeletal anchorage of amputation prostheses.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06753110