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

Launched by SOCIETE DETUDE, DE RECHERCHE ET DE FABRICATION · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the XPEO-E liner, which is used in hip replacement surgeries. The trial aims to gather information about how well the XPEO-E liner works and its safety when used with specific hip components (the NOVAE cups and SERF femoral heads and stems). The goal is to improve patients' quality of life and reduce pain by replacing damaged hip joints.

To participate in the trial, patients need to be adults who require a SERF total hip prosthesis and must meet certain criteria, such as being affiliated with French social security and able to give informed consent. Participants will have regular follow-up visits to monitor their health and will fill out questionnaires to provide feedback about their experience. It’s important to note that individuals who are pregnant, unable to consent, or have certain medical conditions may not be eligible for this study. This trial is not currently recruiting patients, but it aims to ensure that the XPEO-E liner meets safety and performance standards for future use.

Gender

ALL

Eligibility 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.