Clinical and Functional Results After Total Elbow Arthroplasty

May 20, 2021 updated by: François SIRVEAUX, Central Hospital, Nancy, France

Evaluation of the Clinical and Functional Results Obtained After a Total Elbow Arthroplasty, All Indications Combined

Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54000
        • CHRU Nancy

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Every patient that underwent a total elbow arthroplasty between january 2004 and august 2020 by a single operator in our orthopedic center

Description

Inclusion Criteria:

  • Total elbow arthroplasty, all indication combined

Exclusion Criteria:

  • Less than 24 months of follow up
  • Revision of total elbow arthroplasty

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total elbow arthroplasty
Total elbow arthroplasty, all indications combined
Procedure: Total elbow arthroplasty
Total elbow arthroplasty by a single operator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mayo Elbow Performance Score
Time Frame: through study completion, an average of 5 years
through study completion, an average of 5 years
QuickDASH
Time Frame: through study completion, an average of 5 years
through study completion, an average of 5 years
Range of motion
Time Frame: through study completion, an average of 5 years
through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant loosening
Time Frame: through study completion, an average of 5 years
Radiolucent lines around the implant on the X Ray
through study completion, an average of 5 years
Triceps deficiency
Time Frame: through study completion, an average of 5 years
through study completion, an average of 5 years
Bushing wear
Time Frame: through study completion, an average of 5 years
Measure of an angle on the X Ray
through study completion, an average of 5 years

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (Actual)

January 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 18, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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