Actively Recruiting

Age: 18Years +
All Genders
NCT06917365

Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-13

500

Participants Needed

5

Research Sites

335 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female adults
  • Patient needing implantation with a SERF total hip prosthesis
  • Patient meeting Instructions for Use (IFU) requirements
  • Patient affiliated to French social security
  • Patient who has provided a dated and signed informed consent form
Not Eligible

You will not qualify if you...

  • Patient under French legal protection measures (guardianship or curatorship)
  • Patient unable to express consent
  • Patient deprived of liberty or hospitalized against consent
  • Pregnant or breastfeeding patient
  • Patient with contraindication to medical device implantation per instructions for use
  • Patient with contraindication to radiographic follow-up
  • Patient unlikely to comply with follow-up visit schedule
  • Patient unable to complete self-questionnaires

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

CHU Dijon

Dijon, France

Actively Recruiting

2

HCL Croix-Rousse

Lyon, France

Actively Recruiting

3

HCL Lyon Sud

Lyon, France

Not Yet Recruiting

4

CHU Saint Etienne

Saint-Etienne, France

Actively Recruiting

5

CHU Strasbourg

Strasbourg, France

Actively Recruiting

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Research Team

C

Clinical department

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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