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

NCT06917365 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-04-13

No results posted yet for this study

Summary

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

  • Total Hip Arthroplasty (THA)

Sponsors & Collaborators

  • Societe dEtude, de Recherche et de Fabrication

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2032-03-31
Completion
2032-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917365 on ClinicalTrials.gov