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

NCT ID: NCT06917365

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2032-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Hip Arthroplasty (THA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Societe dEtude, de Recherche et de Fabrication

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Clinical department

Role: CONTACT

+33472056010

Other Identifiers

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2024-A02261-46

Identifier Type: -

Identifier Source: org_study_id

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