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

NCT05180071 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-12-12

No results posted yet for this study

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.

Conditions

  • Total Elbow Arthroplasty

Interventions

DEVICE

TEMA elbow system

Total elbow replacement

Sponsors & Collaborators

  • Limacorporate S.p.a

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2029-06-30
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180071 on ClinicalTrials.gov