Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups (2024-01-XPEO-E)

Study Research and Manufacturing Company (SERF)

Status: Not yet enrolling

Conditions: Total Hip Arthroplasty (THA)

Study type: Observational

Funder types: Industry

Identifiers

NCT06917365

2024-A02261-46

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.