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NCT04634305 Clinical Trial

Clinical and Functional Results After Total Elbow Arthroplasty

Elbow Fracture Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04634305
Other study ID # 2020PI204
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2004
Est. completion date December 31, 2021

Study information
Verified date May 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 45
Est. completion date December 31, 2021
Est. primary completion date February 1, 2006
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Total elbow arthroplasty, all indication combined Exclusion Criteria: - Less than 24 months of follow up - Revision of total elbow arthroplasty

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Total elbow arthroplasty
Total elbow arthroplasty by a single operator

Locations
Country Name City State
France CHRU Nancy Nancy Lorraine

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mayo Elbow Performance Score through study completion, an average of 5 years
Primary QuickDASH through study completion, an average of 5 years
Primary Range of motion through study completion, an average of 5 years
Secondary Implant loosening Radiolucent lines around the implant on the X Ray through study completion, an average of 5 years
Secondary Triceps deficiency through study completion, an average of 5 years
Secondary Bushing wear Measure of an angle on the X Ray through study completion, an average of 5 years
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Completed NCT05870345 - Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures N/A
Completed NCT05258162 - Comparison of Mobilization and MET Post-Traumatic Elbow Stiffness N/A
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