Clinical and Functional Results After Total Elbow Arthrop... | NCT04634305

Studies
Clinical and Functional Results After Total Elbow Arthroplasty

NCT04634305

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

May 21, 2021Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Elbow Fracture
Elbow Arthropathy
Elbow Osteoarthritis

Interventions

Total elbow arthroplasty

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2004Actual

Primary Completion Date

Feb 1, 2006Actual

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Oct 18, 2020

First Submission Date that Met QC Criteria

Nov 12, 2020

First Posted Date

Nov 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2021

Last Update Posted Date

May 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

François SIRVEAUX, Clinical Professor François Sirveaux, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

72 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total elbow arthroplasty		Total elbow arthroplasty, all indications combined	Procedure: Total elbow arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total elbow arthroplasty	Procedure	Total elbow arthroplasty by a single operator	Total elbow arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Total elbow arthroplasty, all indication combined

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Nancy		Nancy	Lorraine	54000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092482	Elbow Fractures

Ancestor Terms

ID	Term
D000092464	Elbow Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057929	Arthroplasty, Replacement, Elbow

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided