RecruitingNot Applicable

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

Australia, Austria, Belgium70 participantsStarted 2025-02-19

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Implant Safety and Effectivness

Timeframe: 2 years post implant surgery

Trial details

NCT IDNCT06753110

SponsorIntegrum

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Chief Medical Officer, MD

+46 706753499 karin.ganlov@integrum.se

View on ClinicalTrials.gov More Amputation of Upper Limb trials