XPEO-E liner with SERF dual-mobility hip cups for total hip replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational post-market data collection of the XPEO-E polyethylene liner used with NOVAE cups and SERF femoral heads and stems in routine total hip arthroplasty. Participants receive the devices according to their CE marking and usual surgical practice, and follow-up visits follow standard clinical care. Additional data are collected via patient- and surgeon-completed questionnaires to capture function, pain, and device performance. The goal is to gather device-specific clinical data to support regulatory transition to MDR 2017/745 in the EU.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Dijon
  Dijon, France Recruiting
• HCL Croix-Rousse
  Lyon, France Recruiting
• CHU Saint Etienne
  Saint-Etienne, France Recruiting
• CHU Strasbourg
  Strasbourg, France Recruiting
• HCL Lyon Sud
  Lyon, France Not yet recruiting

Study contacts

• Study coordinator: Clinical department
• Email: clinical@serf.fr
• Phone: +33472056010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.