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Hip Prospective Study | Clinical Trials | Clareo Health

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RECRUITINGNCT05956236

Hip Prospective Study

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 F...

Lead sponsor: Societe dEtude, de Recherche et de Fabrication•1 locations•View source on ClinicalTrials.gov

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Contacts

Clinical department

CONTACT

0472056010 clinical@serf.fr

Sponsors

Lead Sponsor

Societe dEtude, de Recherche et de Fabrication

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 12, 2024Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment5,000

Start dateApr 2023

Last updatedJul 12, 2024

Condition

Hip Arthropathy

Locations shown

CHU St Etienne

Saint-Priest-en-Jarez

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions