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

Recruiting now

Conditions studied: Total Hip Arthroplasty (THA)

In brief

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.

Key facts

Study ID

NCT06917365

Run by

Societe dEtude, de Recherche et de Fabrication

People needed

500

Starts

2025-10-27

Expected to finish

2032-03-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CHU Dijon — Dijon, France (enrolling)
• HCL Croix-Rousse — Lyon, France (enrolling)
• CHU Saint Etienne — Saint-Etienne, France (enrolling)
• CHU Strasbourg — Strasbourg, France (enrolling)
• HCL Lyon Sud — Lyon, France

Full record on ClinicalTrials.gov

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