TEMA elbow system is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within five years after the surgery, and thus to assess the short-term performance and safety of this implant.
Patient's age ≥ 18 years old.
Patient has given written informed consent to participate to the trial and to his/her personal data processing
Elbow joint destruction which significantly compromises the activities of daily living
Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis with hemophilia.
Local or systemic infection;
Septicemia;
Persistent acute or chronic osteomyelitis.
Uncooperative patient or patient with neurologic disorders who are incapable of following directions;
Single group
TEMA elbow system
DeviceTotal elbow replacement
Oxford Elbow Score improvement at three ears FU
Functional change in Oxford Elbow Score (OES) from preoperative (baseline) to 2 years of follow-up.
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This trial is not recruiting at the moment. You can still explore other options:
