Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device (ESOP2)

January 29, 2026 updated by: FH ORTHO

Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Clinique Tivoli Ducos
      • Bordeaux, France, 33000
        • Nouvelle Clinique Bel-Air
      • Colmar, France, 68024
        • CH Pasteur
      • Garches, France, 92380
        • CH Raymond POINCARE
      • Haguenau, France, 67504
        • CH de Haguenau
      • Paris, France, 75651
        • Groupe Hospitalier Pitie-Salpetriere
      • Écully, France, 69130
        • Clinique du Val d'Ouest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients receiving ESOP 2 stem
Device: Hip prosthesis - ESOP 2 cementless femoral stem
ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: 10 years post-op
10 years post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographies evaluation
Time Frame: immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
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
Time Frame: per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
All complications will be gathered during intervention and up to 10 years postoperatively.
per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility
Time Frame: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Functional outcomes will be determined by the Harris Hip score. This score ranges from 0 to 100, where, the higher the score, the better the patient outcome.
pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Quality of life evaluation
Time Frame: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Quality of life will be determined by the OXFORD-12 score. This score ranges from 12 points to 60 points, where, the higher the score, the better the patient outcome.
pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FH ORTHO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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