NCT04634305

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
14.7 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

October 18, 2020

Last Update Submit

May 20, 2021

Conditions

Elbow FractureElbow ArthropathyElbow Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Mayo Elbow Performance Score

    through study completion, an average of 5 years

  • QuickDASH

    through study completion, an average of 5 years

  • Range of motion

    through study completion, an average of 5 years

Secondary Outcomes (3)

  • Implant loosening

    through study completion, an average of 5 years

  • Triceps deficiency

    through study completion, an average of 5 years

  • Bushing wear

    through study completion, an average of 5 years

Study Arms (1)

Total elbow arthroplasty

Total elbow arthroplasty, all indications combined

Procedure: Total elbow arthroplasty

Interventions

Total elbow arthroplastyPROCEDURE

Total elbow arthroplasty by a single operator

Total elbow arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Total elbow arthroplasty, all indication combined

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, Lorraine, 54000, France

Location

MeSH Terms

Conditions

Elbow Fractures

Interventions

Arthroplasty, Replacement, Elbow

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
72 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor François Sirveaux

Study Record Dates

First Submitted

October 18, 2020

First Posted

November 18, 2020

Study Start

January 1, 2004

Primary Completion

February 1, 2006

Study Completion

December 31, 2021

Last Updated

May 21, 2021

Record last verified: 2021-05

Locations

FR(1)