Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
ConditionTotal Hip Arthroplasty (THA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociete dEtude, de Recherche et de Fabrication
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov