Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
NCT ID: NCT06917365
Last Updated: 2025-04-23
Study Results
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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NOT_YET_RECRUITING
500 participants
OBSERVATIONAL
2025-05-01
2032-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Societe dEtude, de Recherche et de Fabrication
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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2024-A02261-46
Identifier Type: -
Identifier Source: org_study_id
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