Clinical Performance of XPEO-E Liner in SERF Dual-mobilit... | NCT06917365

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

NCT06917365

Sponsor

Societe dEtude, de Recherche et de Fabrication

Status

Recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Total Hip Arthroplasty (THA)

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2025Actual

Primary Completion Date

Mar 31, 2032Estimated

Completion Date

Mar 31, 2032Estimated

First Submitted Date

Apr 1, 2025

First Submission Date that Met QC Criteria

Apr 1, 2025

First Posted Date

Apr 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Survival rate	Calculated using the Kaplan-Meier method	Per operative period to 5 years
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 )

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample