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NCT06917365 | NOT YET RECRUITING | Total Hip Arthroplasty (THA)

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

SOCIETY DESTURE, RESEARCH AND MANUFACTURE

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 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.

Condition or disease

Total Hip Arthroplasty (THA)

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2032-03-31
Estimated Study Completion Date : 2032-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Criteria
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.
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

Location Details

NCT06917365

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