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

December 11, 2023 updated by: Limacorporate S.p.a
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

59

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEMA elbow arthroplasty
Device: TEMA elbow system
Total elbow replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Elbow Score improvement at three ears FU
Time Frame: 2 years Follow up
Functional change in Oxford Elbow Score (OES) from preoperative (baseline) to 2 years of follow-up.
2 years Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limacorporate S.p.a

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • E-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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