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.
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
Subject not willing to consent
Subject implanted with the e-OPRA system at the humeral level.
Single group
OPRA transhumeral
DeviceSkeletal anchorage of amputation prostheses.
Implant Safety and Effectivness
Implant safety: \* Implant survival rate 2 years post implant surgery. Calculated the number of implants still in situ at time of the follow-up visit, 2 years after completion of implant surgery divided by the number of implants at risk. Effectivness: \* Change in prosthetic use. Measured as time prosthesis used before implant surgery compared with time prosthesis used at time of the follow-up visit. Categorized as: * Hours per day * Days per week.
Implant Safety
• Implant survival rate, after 6 months, and 1-, 5-, 10- and ˃10-years post implant surgery. Calculated as the number of implants still in situ after 6 months, 1-, 5-, 10- and ˃10-years after completion of surgery divided by the number of implants at risk
Implant Safety
• Implant survival time Measured as the time from completion of surgery to implant loss or time of last observation without known implant loss.
Implant safety
• Presence of biological complications Measured as the number of the following complications taking place from time of surgery to time of implant loss or time of last observation without known implant loss: * Infections * Skin complications * Skeletal complications
Implant safety
• Presence of Mechanical complications Mechanical complications related to implant, abutment or abutment screw. Measured as the number of mechanical complications taking place from time of surgery to implant loss our time of last observation without known implant loss, presented per category: * Implant related * Abutment related * Abutment screw related
