Hip Prospective Study

Hip Arthropathy Clinical Trial

Official title:

Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956236
• Other study ID #: HiPS
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: April 2046

Study information

• Verified date: May 2023
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: Clinical department
• Phone: 0472056010
• Email: clinical[@]serf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: April 2046
• Est. primary completion date: April 2046
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Locations

Country	Name	City	State
France	CHU St Etienne	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration	Per operative period to 15 years
Secondary	Intermediate survival rates	To assess the survival rate of the investigational medical devices at the intermediate timepoints	Per operative period to 10 years
Secondary	Functional improvement	To assess the evolution of patient's functional capacity post-implantation using HOOS score	Per operative period to 15 years
Secondary	Functional improvement	To assess the evolution of patient's functional capacity post-implantation using Harris Hips score	Per operative period to 15 years
Secondary	Functional improvement	To assess the evolution of patient's activity post-implantation using UCLA scale	Per operative period to 15 years
Secondary	Functional improvement	To assess the evolution of patient's activity post-implantation using Charnley score	Per operative period to 15 years
Secondary	Leg length discrepancy	To assess patient's leg length discrepancy post-implantation (visual evaluation)	Pre operative period to 15 years
Secondary	Patient's Pain	To assess patient's pain (Visual Analogic Scale)	Pre operative period to 15 years
Secondary	Patient's quality of life	To assess patient's quality of life post-implantation (Forgotten Joint Score)	Pre operative period to 15 years
Secondary	Patient's satisfaction	To assess patients' satisfaction with the operation (4-points question)	Post operative period to 15 years
Secondary	Surgeon's satisfaction	To assess surgeons' satisfaction with the operation	Per operative period to 15 years
Secondary	Adverse events	To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery	Per operative period to 15 years