Clinical trial NCT06917365: Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
Official title: Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Total Hip Arthroplasty (THA)
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population, with the exception of pregnant or nursing women, consists exclusively of patients who have reached bone maturity (mainly over 65 years of age) with acute pain and/or an ailing joint resulting from a medical condition (mentioned in paragraph "Medical indications") and insufficiently improved by an alternative treatment options, after a period of observation of a few weeks to a few months, and not exhibiting any contraindications (mentioned in paragraph "Contraindications").

Whatever the medical application, it should be noted that dual mobility cups and liners are particularly appropriate for patients with a high risk of dislocation (serious neurological defects, neuropsychiatric issues, severe neuromuscular deficiencies and dependencies) or with a history of recurring dislocation.

Brief summary: 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 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.

Primary outcomes:
measure: Functional improvement
timeFrame: Per operative period to 5 years
Secondary outcomes:
measure: Survival rate
timeFrame: Per operative period to 5 years
measure: Functional improvement
timeFrame: Per operative period to 5 years
measure: Functional improvement
timeFrame: Per operative period to 5 years
measure: Pain release
timeFrame: Pre operative period to 5 years
measure: Patient's quality of life
timeFrame: Pre operative period to 5 years
measure: Patient's satisfaction
timeFrame: Post operative period to 5 years
measure: Adverse events
timeFrame: Per operative period to 5 years
Other outcomes:
Locations:
Study officials:
References: