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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEMA elbow arthroplasty | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEMA elbow system | Device | Total elbow replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Elbow Score improvement at three ears FU | Functional change in Oxford Elbow Score (OES) from preoperative (baseline) to 2 years of follow-up. | 2 years Follow up |
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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:
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:
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
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