Hip ArthropathyNCT05956236
Hip Prospective Study
An observational study of Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
Trial summary
In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2023to Apr 2046
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients corresponding to the target treated population of the investigational medical devices, planned to be implanted with investigational medical devices per the Instructions for Use (IFU), who can participate to a clinical investigation, are not vulnerable and can meet the follow-up visits (a priori) and fulfil a self-assessment questionnaire will be included.
Who may be able to join
- Male or female adults
- Planned to be implanted with investigational medical devices per the IFUs:
- Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and/or disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months
- Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)
- For an intended purpose and indication listed in the IFUs
- Affiliated to French social security
- Who provided a dated and signed informed consent form
Who cannot join
- Patient protected by a French legal measure
- Patient not able to express his/her consent as deemed by the investigator
- Patient deprived of liberty or hospitalized without consent
- Pregnant or breastfeeding women
- Patient contraindicated to investigational medical devices implantation per the IFUs
- Patient contraindicated to radiographic follow-up
- Patient a priori not able to meet the follow-up visits as deemed by the investigator
- Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU St Etienne
Saint-Priest-en-Jarez, 42270
Boyer Bertrand
About this study
Official title: Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable.
Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses.
HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.
- Conditions
- Hip Arthropathy
- Keywords
- Hip arthropalsty, Hip Prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration
Measured: Per operative period to 15 years
Secondary outcomes (11)
Intermediate survival rates
To assess the survival rate of the investigational medical devices at the intermediate timepoints
Measured: Per operative period to 10 years
Functional improvement
To assess the evolution of patient's functional capacity post-implantation using HOOS score
Measured: Per operative period to 15 years
Functional improvement
To assess the evolution of patient's functional capacity post-implantation using Harris Hips score
Measured: Per operative period to 15 years
Functional improvement
To assess the evolution of patient's activity post-implantation using UCLA scale
Measured: Per operative period to 15 years
Functional improvement
To assess the evolution of patient's activity post-implantation using Charnley score
Measured: Per operative period to 15 years
Leg length discrepancy
To assess patient's leg length discrepancy post-implantation (visual evaluation)
Measured: Pre operative period to 15 years
Patient's Pain
To assess patient's pain (Visual Analogic Scale)
Measured: Pre operative period to 15 years
Patient's quality of life
To assess patient's quality of life post-implantation (Forgotten Joint Score)
Measured: Pre operative period to 15 years
Patient's satisfaction
To assess patients' satisfaction with the operation (4-points question)
Measured: Post operative period to 15 years
Surgeon's satisfaction
To assess surgeons' satisfaction with the operation
Measured: Per operative period to 15 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 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start24 Apr 2023
- Primary completionApr 2046 (estimated)
- Study completionApr 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies 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
- 5,000 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
- NCT05956236
- Sponsor's protocol ID
- HiPS
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
- ClinicalTrials.gov ID
- NCT05956236
- Acronym / sponsor ID
- HiPS
- Conditions
- Hip Arthropathy
- Keywords
- Hip arthropalsty, Hip Prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- Apr 2046 (estimated)
- Study completion
- Apr 2046 (estimated)
- First posted
- 21 Jul 2023 (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.
In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable.
Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses.
HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients corresponding to the target treated population of the investigational medical devices, planned to be implanted with investigational medical devices per the Instructions for Use (IFU), who can participate to a clinical investigation, are not vulnerable and can meet the follow-up visits (a priori) and fulfil a self-assessment questionnaire will be included.
Key inclusion criteria (7 listed)
- Male or female adults
- Planned to be implanted with investigational medical devices per the IFUs:
- Affiliated to French social security
- Who provided a dated and signed informed consent form
Key exclusion criteria (8 listed)
- Patient protected by a French legal measure
- Patient not able to express his/her consent as deemed by the investigator
- Patient deprived of liberty or hospitalized without consent
- Pregnant or breastfeeding women
- Patient contraindicated to investigational medical devices implantation per the IFUs
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
Survival rate
Time frame: Per operative period to 15 years
To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration
11 secondary outcomes
Intermediate survival rates
Time frame: Per operative period to 10 years
Functional improvement
Time frame: Per operative period to 15 years
Functional improvement
Time frame: Per operative period to 15 years
Functional improvement
Time frame: Per operative period to 15 years
Functional improvement
Time frame: Per operative period to 15 years
Leg length discrepancy
Time frame: Pre operative period to 15 years
Patient's Pain
Time frame: Pre operative period to 15 years
Patient's quality of life
Time frame: Pre operative period to 15 years
Patient's satisfaction
Time frame: Post operative period to 15 years
Surgeon's satisfaction
Time frame: Per operative period to 15 years
Adverse events
Time frame: Per operative period to 15 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 14 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site 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 7 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 14 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 1 site 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 (0472056010 ext. +33, clinical@serf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: Per operative period to 15 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 14 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.