Hip Prospective Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Arthropathy

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Clinical Department; Phone Number: +33 0472056010; Email: clinical@serf.fr

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • Recruiting
    • CHU ST Etienne
    • Contact: Boyer Bertrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients corresponding to the target treated population of the investigational medical devices, planned to be implanted with investigational medical devices per the Instructions for Use (IFU), who can participate to a clinical investigation, are not vulnerable and can meet the follow-up visits (a priori) and fulfil a self-assessment questionnaire will be included.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermediate survival rates	To assess the survival rate of the investigational medical devices at the intermediate timepoints	Per operative period to 10 years
Functional improvement	To assess the evolution of patient's functional capacity post-implantation using HOOS score	Per operative period to 15 years
Functional improvement	To assess the evolution of patient's functional capacity post-implantation using Harris Hips score	Per operative period to 15 years
Functional improvement	To assess the evolution of patient's activity post-implantation using UCLA scale	Per operative period to 15 years
Functional improvement	To assess the evolution of patient's activity post-implantation using Charnley score	Per operative period to 15 years
Leg length discrepancy	To assess patient's leg length discrepancy post-implantation (visual evaluation)	Pre operative period to 15 years
Patient's Pain	To assess patient's pain (Visual Analogic Scale)	Pre operative period to 15 years
Patient's quality of life	To assess patient's quality of life post-implantation (Forgotten Joint Score)	Pre operative period to 15 years
Patient's satisfaction	To assess patients' satisfaction with the operation (4-points question)	Post operative period to 15 years
Surgeon's satisfaction	To assess surgeons' satisfaction with the operation	Per operative period to 15 years
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

Collaborators and Investigators

• Sponsor: Societe dEtude, de Recherche et de Fabrication

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Estimated): April 1, 2046
• Study Completion (Estimated): April 1, 2046

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hip Prosthesis; Hip arthropalsty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: HiPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No