Hip Prospective Study

Launched by SOCIETE DETUDE, DE RECHERCHE ET DE FABRICATION · Jul 13, 2023

Keywords

ClinConnect Summary

The Hip Prospective Study (HiPS) is a clinical trial aimed at understanding the long-term performance, safety, and benefits of specific hip prostheses for patients suffering from hip arthropathy, a condition that causes severe hip pain and disability. This study is important because it helps gather real-life data on how these devices work over time, which is required by health authorities in France and Europe.

To participate in this study, you need to be an adult aged 60 or older who is planning to receive a specific type of hip implant made by the manufacturer SERF. This study is open to both men and women who have not found relief from other treatments and are facing significant pain or difficulty with movement. If you join, you’ll be monitored for 15 years, and you can expect regular follow-up visits to assess your progress and answer any questions. It’s important to note that there are some exclusions, such as being pregnant or unable to provide consent, so it’s best to discuss your eligibility with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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.