Observational Study Conducted on Patients Receiving the E... | NCT04193163

Studies
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device

NCT04193163

Sponsor

FH ORTHO

Status

Terminated

Last Update Posted

Feb 2, 2026Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Hip Disease
Hip Fractures

Interventions

Hip prosthesis - ESOP 2 cementless femoral stem

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Discontinuation of the studied medical device on the market and not enough inclusion in the study.

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Sep 1, 2022Actual

Completion Date

Sep 1, 2022Actual

First Submitted Date

Nov 28, 2019

First Submission Date that Met QC Criteria

Dec 6, 2019

First Posted Date

Dec 10, 2019Actual

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

Jan 29, 2026

Last Update Posted Date

Feb 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.

Detailed Description

The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up.

The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving ESOP 2 stem			Device: Hip prosthesis - ESOP 2 cementless femoral stem

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hip prosthesis - ESOP 2 cementless femoral stem	Device	ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival rate		10 years post-op

Secondary Outcomes

Measure	Description	Time Frame
Radiographies evaluation	Radiological results such as stability, osteointegration will be evaluated.	immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Rate of complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
Subject who received an information form and is willing to participate in the study

Exclusion Criteria:

Contraindications described in the instructions for use
Usual surgical contraindications
Subject who is not able to express his/her non-opposition

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

Patients from participating hospitals will be enrolled as part of their clinical routine care.

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 Tivoli Ducos		Bordeaux		33000	France
Nouvelle Clinique Bel-Air

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

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided