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โ† Trials
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Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

Recruitingn/aAges 18 Years - anyAllSociete dEtude, de Recherche et de Fabrication
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

5 sites
CHU Dijon
Dijon, France
HCL Croix-Rousse
Lyon, France
HCL Lyon Sud
Lyon, France
CHU Saint Etienne
Saint-Etienne, France
CHU Strasbourg
Strasbourg, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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