Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

NCT06917365 | Recruiting

• 1 other identifier: 2024-A02261-46
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 5

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.

Conditions

Total Hip Arthroplasty (THA)

Outcome Measures

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)

  Per operative period to 5 years

Secondary Outcomes (7)

• Survival rate

  Per operative period to 5 years

• Functional improvement

  Per operative period to 5 years

• Functional improvement

  Per operative period to 5 years

• Pain release

  Pre operative period to 5 years

• Patient's quality of life

  Pre operative period to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (5)

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

Central Study Contacts

Clinical department

CONTACT

+33472056010; clinical@serf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2032
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (5)