Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2023-04-24
2046-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Societe dEtude, de Recherche et de Fabrication
INDUSTRY
Responsible Party
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Locations
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CHU St Etienne
Saint-Priest-en-Jarez, , France
Countries
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Central Contacts
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Facility Contacts
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Boyer Bertrand
Role: primary
Other Identifiers
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HiPS
Identifier Type: -
Identifier Source: org_study_id
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