Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
ConditionTotal Hip Arthroplasty (THA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociete dEtude, de Recherche et de Fabrication
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Functional improvement
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)
Time frame
Per operative period to 5 yearsSecondary outcomes
1
Survival rate
Calculated using the Kaplan-Meier method
Time frame
Per operative period to 5 years2
Functional improvement
To assess the evolution of patient's functional capacity post-implantation using HOOS score (40-item questionnaire mesured from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms )
Time frame
Per operative period to 5 years3
Functional improvement
To assess the evolution of patient's activity post-implantation using Charnley score
Time frame
Per operative period to 5 years4
Pain release
To assess patient's pain (Visual Analogic Scale measured on a scale of 0 to 10 to reflect the intensity of the pain)
Time frame
Pre operative period to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov