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

Launched by LIMACORPORATE S.P.A · Dec 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the TEMA elbow system, a medical device used in total elbow replacement surgery. The main goal of the trial is to gather information about how well this device works and its safety over a five-year period after surgery. Researchers will look at different measures of patient health, including how well patients can use their elbow and any problems that arise after the surgery.

To be eligible for this study, participants must be at least 18 years old and have serious issues with their elbow that affect their daily activities, such as arthritis or severe injuries. They should have already received the TEMA elbow implant and be willing to follow the study rules. The trial is not yet recruiting participants, but it welcomes individuals of all genders who meet these criteria. Participants can expect to be monitored for their recovery and the overall performance of the implant, contributing valuable information to help improve elbow replacement surgeries in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient's age ≥ 18 years old.
• • 2. Patient has given written informed consent to participate to the trial and to his/her personal data processing
• 3. 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
• • 4. Patient has undergone a total elbow arthroplasty, receiving TEMA prosthesis.
• • 5. 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:
• 1. 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.
• • 2. Patient suffers from a diaphyseal fracture
• • 3. For female patients, current pregnancy and/or lactation or planning a pregnancy.
• • 4. Only for patients implanted with the unlinked configuration of TEMA prosthesis, the intraoperative testing showed a bad quality of medial and lateral elbow ligaments.
• • 5. Patient is enrolled in another investigational drug/device study that in the opinion of the Investigator could interfere with this clinical trial