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
Recruiting
N/A
Interventional Study
Amputation of Upper Limb
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- Integrum · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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.
Trial Locations
Loading…
Loading trial locations…
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 …
Contacts