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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Functional improvement — Per operative period to 5 years To assess the evolution of patient's functional capacity post-implantation using Harris Hips score (measured from 0 to 100 points, the higher the score the better the outcome)
Trial sites (5)
Facility
City
Region
Status
CHU Dijon
Dijon
France
Recruiting
HCL Croix-Rousse
Lyon
France
Recruiting
HCL Lyon Sud
Lyon
France
Not Yet Recruiting
CHU Saint Etienne
Saint-Etienne
France
Recruiting
CHU Strasbourg
Strasbourg
France
Recruiting
More Societe dEtude, de Recherche et de Fabrication trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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