Post Market Clinical Follow-up of EUROSTEM Femoral Stem | NCT04995822

Studies
Post Market Clinical Follow-up of EUROSTEM Femoral Stem

NCT04995822

Sponsor

EUROS

Status

Active, not recruiting

Last Update Posted

Feb 20, 2024Actual

Enrollment

131Estimated

Phase

Not provided

Conditions

Hip Osteoarthritis
Hip Arthropathy
Hip Arthritis
Hip Necrosis
Hip Fractures
Hip Dysplasia

Interventions

hip 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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2021Actual

Primary Completion Date

Nov 6, 2022Actual

Completion Date

Nov 6, 2032Estimated

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 9, 2021Actual

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

Feb 16, 2024

Last Update Posted Date

Feb 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

EUROSSTEM is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

Detailed Description

Post market observational study. This study is multicenter, prospective, non comparative.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

131Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUROSTEM femoral stem		All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless)	Device: hip arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hip arthroplasty	Device	Hip prosthesis surgery	EUROSTEM femoral stem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of EUROSTEM Femoral Stem	Collect the safety of the device trought complications occurence rate	1 year

Secondary Outcomes

Measure	Description	Time Frame
Radiological performances of EUROSTEM Femoral Stem	Collect the performances of the device trought radiological evaluation	1 year
Clinical performances of EUROSTEM Femoral Stem	Collect the performances of the device trought clinical scores

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who received EUROSTEM
Patient informed of its participation to the study
Patient aged over 18 to date of surgery

Exclusion Criteria:

Patient presenting a contraindication to EUROSTEM implantation.
Patient who refused to participate to the study
Vulnerable subjects

Accepts Healthy Volunteers

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

Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSTEM

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique du Mail		Puilboreau	La Rochelle	17138	France
Clinique Esquirol St Hilaire

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Feb 27, 2025
Reset	Mar 14, 2025
Release	Jul 31, 2025
Reset	Aug 20, 2025

Submission Tracking

Estimated Results First Submitted Date

Feb 27, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 27, 2025			Mar 14, 2025
Jul 31, 2025

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip
D006620	Hip Fractures
D006617	Hip Dislocation

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided