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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLimacorporate S.p.a

About this trial

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.

Eligibility criteria

Qualifiers

Patient's age ≥ 18 years old.

Patient has given written informed consent to participate to the trial and to his/her personal data processing

Elbow joint destruction which significantly compromises the activities of daily living

Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis with hemophilia.

Disqualifiers

Local or systemic infection;

Septicemia;

Persistent acute or chronic osteomyelitis.

Uncooperative patient or patient with neurologic disorders who are incapable of following directions;

Trial design

Treatments tested in this trial

  • TEMA elbow system

Treatment groups

59 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators