Clinical Trial

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

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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-12-17; most recent amendment 2023-12-11.
Trial Details
NCT Number NCT05180071
Lead Sponsor Limacorporate S.p.a
Conditions Total Elbow Arthroplasty
Enrollment 59 participants
Start Date 2024-02-01
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2023-12-12