Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Total Hip Arthroplasty (THA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Functional improvement [Time frame: Per operative period to 5 years]
Secondary outcome measures (7)
- Survival rate [Time frame: Per operative period to 5 years]
- Functional improvement [Time frame: Per operative period to 5 years]
- Functional improvement [Time frame: Per operative period to 5 years]
- Pain release [Time frame: Pre operative period to 5 years]
- Patient's quality of life [Time frame: Pre operative period to 5 years]
- Patient's satisfaction [Time frame: Post operative period to 5 years]
- Adverse events [Time frame: Per operative period to 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 5 centers
- CHU Dijon — Dijon
- HCL Croix-Rousse — Lyon
- HCL Lyon Sud — Lyon
- CHU Saint Etienne — Saint-Etienne
- CHU Strasbourg — Strasbourg
Identifiers
NCT: NCT06917365 · 2024-A02261-46