A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA

Inclusion criteria

• Patient's age ≥ 18 years old.
• Patient has given written informed consent to participate to the trial and to his/her personal data processing
• According to the device indications for use, patient suffers from disability due to one or more of the following:

• Elbow joint destruction which significantly compromises the activities of daily living
• Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis with hemophilia.
• Rheumatoid arthritis or degenerative arthritis with incapacitating pain
• Correction of severe functional deformity.
• Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
• Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
• Any other medical reason that the investigator determine that subject is a good candidate for a total elbow arthroplasty
• Patient has undergone a total elbow arthroplasty, receiving TEMA prosthesis.
• Patient is able to comply with the study protocol.

Exclusion criteria

A patient will be excluded from the study participation if he/she meets any of the following criteria:

• Patient is affected by one or more of the conditions that are stated as TEMA contraindications for use, which are:

• Local or systemic infection;
• Septicemia;
• Persistent acute or chronic osteomyelitis.
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions;
• Osteoporosis;
• Metabolic disorders which may impair bone formation;
• Rapid joint destruction, marked bone loss or bone resorption.
• Patient suffers from a diaphyseal fracture
• For female patients, current pregnancy and/or lactation or planning a pregnancy.
• Only for patients implanted with the unlinked configuration of TEMA prosthesis, the intraoperative testing showed a bad quality of medial and lateral elbow ligaments.
• Patient is enrolled in another investigational drug/device study that in the opinion of the Investigator could interfere with this clinical trial