Hip Prospective Study | NCT05956236

Studies
Hip Prospective Study

NCT05956236

Sponsor

Societe dEtude, de Recherche et de Fabrication

Status

Recruiting

Last Update Posted

Apr 14, 2026Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Hip Arthropathy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2023Actual

Primary Completion Date

Apr 2046Estimated

Completion Date

Apr 2046Estimated

First Submitted Date

Mar 23, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample