Status:
NOT_YET_RECRUITING
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
Lead Sponsor:
Societe dEtude, de Recherche et de Fabrication
Conditions:
Total Hip Arthroplasty (THA)
Eligibility:
All Genders
18+ years
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2032
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06917365
Start Date
May 1 2025
End Date
March 31 2032
Last Update
April 23 2025
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