Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups (2024-01-XPEO-E)

April 9, 2026 updated by: Societe dEtude, de Recherche et de Fabrication

XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU).

XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint.

The follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and/or the surgeons.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Dijon, France
      • Lyon, France
      • Lyon, France
      • Saint-Etienne, France
        • Recruiting
        • CHU Saint Etienne
        • Contact:
        • Principal Investigator:
          • Pr Farizon
        • Principal Investigator:
          • Pr Philippot
      • Strasbourg, France

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The target population, with the exception of pregnant or nursing women, consists exclusively of patients who have reached bone maturity (mainly over 65 years of age) with acute pain and/or an ailing joint resulting from a medical condition (mentioned in paragraph "Medical indications") and insufficiently improved by an alternative treatment options, after a period of observation of a few weeks to a few months, and not exhibiting any contraindications (mentioned in paragraph "Contraindications").

Whatever the medical application, it should be noted that dual mobility cups and liners are particularly appropriate for patients with a high risk of dislocation (serious neurological defects, neuropsychiatric issues, severe neuromuscular deficiencies and dependencies) or with a history of recurring dislocation.

Description

Inclusion Criteria:

  • Male or female adults.
  • Patient that needs to be implanted with a SERF total hip prosthesis.
  • Patient responding to IFU requirement.
  • Patient affiliated to French social security.
  • Patient who has provided a dated and signed informed consent form.

Exclusion Criteria:

  • Patient protected by a French legal measure (under legal protection, guardianship or curatorship).
  • Patient unable of expressing consent, according to the investigator.
  • Patient deprived of liberty or hospitalized against his consent.
  • Pregnant or breastfeeding patient.
  • Patient presenting a contraindication to the implantation of medical devices according to the instructions for use.
  • Patient with a contraindication to radiographic follow-up.
  • Patient not being, a priori, capable of respecting the schedule of follow-up visits, according to the investigator.
  • Patient unable to complete a self-questionnaire, according to the investigator.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional improvement
Time Frame: Per operative period to 5 years
To assess the evolution of patient's functional capacity post-implantation using Harris Hips score (measured from 0 to 100 points, the higher the score the better the outcome)
Per operative period to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: Per operative period to 5 years
Calculated using the Kaplan-Meier method
Per operative period to 5 years
Functional improvement
Time Frame: Per operative period to 5 years
To assess the evolution of patient's activity post-implantation using Charnley score
Per operative period to 5 years
Patient's satisfaction
Time Frame: Post operative period to 5 years
To assess patients' satisfaction with the operation (4-points question)
Post operative period to 5 years
Adverse events
Time Frame: Per operative period to 5 years
To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery
Per operative period to 5 years
Functional improvement
Time Frame: Per operative period to 5 years
To assess the evolution of patient's functional capacity post-implantation using HOOS score (40-item questionnaire mesured from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms )
Per operative period to 5 years
Pain release
Time Frame: Pre operative period to 5 years
To assess patient's pain (Visual Analogic Scale measured on a scale of 0 to 10 to reflect the intensity of the pain)
Pre operative period to 5 years
Patient's quality of life
Time Frame: Pre operative period to 5 years
To assess patient's quality of life post-implantation (Forgotten Joint Score mesured from 0 to 100, the higher the score, the less the patient is aware of their affected joint when performing daily activities)
Pre operative period to 5 years

Collaborators and Investigators

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

Sponsor

Societe dEtude, de Recherche et de Fabrication

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)

October 27, 2025

Primary Completion (Estimated)

March 31, 2032

Study Completion (Estimated)

March 31, 2032

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-A02261-46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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