Long-term evaluation of hip prostheses performance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather long-term clinical data on hip prostheses as part of the Post-Market Clinical Follow-up (PMCF) process mandated by European regulations. It will involve a multicentric, prospective investigation over a 15-year period, focusing on the safety, performance, and benefits of these devices in real-life settings. Participants will be adults who are scheduled to receive specific hip implants from the manufacturer SERF, following an observation period of alternative treatments. The study is designed to ensure compliance with health authority requirements and improve patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU St Etienne
  Saint-Priest-en-Jarez, France Recruiting

Study contacts

• Study coordinator: Clinical department
• Email: clinical@serf.fr
• Phone: 0472056010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.