Total Hip Arthroplasty (THA)2024-01-XPEO-ENCT06917365
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
An observational study of Total Hip Arthroplasty (THA), run by Societe dEtude, de Recherche et de Fabrication at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- How many people
- 500 participants
- Where
- 5 sitesFrance
- Study dates
- 27 Oct 2025to 31 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Dijon
Dijon
Pr Baulot, +33472056010, clinical_serf@stryker.com
- Recruiting
HCL Croix-Rousse
Lyon
Pr Lustig, +33472056010, clinical_serf@stryker.com
- Not yet recruiting
HCL Lyon Sud
Lyon
Pr Fessy, +33472056010, clinical_serf@stryker.com
- Recruiting
CHU Saint Etienne
Saint-Etienne
Pr Philippot, +33472056010, clinical_serf@stryker.com
Pr Farizon
- Recruiting
CHU Strasbourg
Strasbourg
Pr Bonnomet, +33472056010, clinical_serf@stryker.com
About this study
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Per operative period to 5 years
Secondary outcomes (7)
Survival rate
Calculated using the Kaplan-Meier method
Measured: 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 )
Measured: Per operative period to 5 years
Functional improvement
To assess the evolution of patient's activity post-implantation using Charnley score
Measured: Per operative period to 5 years
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)
Measured: Pre operative period to 5 years
Patient's quality of life
To assess patient's quality of life post-implantation (Forgotten Joint Score mesured from 0 to 100, the higher the score, the less the patient is aware of their affected joint when performing daily activities)
Measured: Pre operative period to 5 years
Patient's satisfaction
To assess patients' satisfaction with the operation (4-points question)
Measured: Post operative period to 5 years
Adverse events
To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery
Measured: Per operative period to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start27 Oct 2025
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societe dEtude, de Recherche et de Fabrication
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917365
- Sponsor's protocol ID
- 2024-A02261-46
- Acronym
- 2024-01-XPEO-E
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
- ClinicalTrials.gov ID
- NCT06917365
- Acronym / sponsor ID
- 2024-01-XPEO-E / 2024-A02261-46
- Conditions
- Total Hip Arthroplasty (THA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional improvement
Time frame: Per operative period to 5 years
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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty (THA), run by Societe dEtude, de Recherche et de Fabrication at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical department (+33472056010, clinical@serf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional improvement (time frame: Per operative period to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.