Prospective and Obsevational Study of Total Hip Prothesis... | NCT05560022

Studies
Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

NCT05560022

Sponsor

Societe dEtude, de Recherche et de Fabrication

Status

Withdrawn

Last Update Posted

Apr 24, 2026Actual

Enrollment

0Actual

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This record is a duplicate. The study is already registered on ClinicalTrials.gov under another NCT number. No participants were enrolled in this duplicate record.

Expanded Access Info

Start Date

Dec 5, 2017Actual

Primary Completion Date

Jan 20, 2031Estimated

Completion Date

Jan 20, 2031Estimated

First Submitted Date

Sep 26, 2022

First Submission Date that Met QC Criteria

Sep 26, 2022

First Posted Date

Sep 29, 2022Actual

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 21, 2026

Last Update Posted Date

Apr 24, 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

The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .

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

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements	Survival according to Kaplan Meier	per operative period to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Assess the improvement in PMA scores and HHS score as well as patient satisfaction		per operative period to 10 years
Adverse events	Type and occurrence of adverse events	per operative period to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Man or women
Degenerative or inflammatory hip pathology requiring a total hip replacement
Primary or secondary osteoarthritis
Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
Fracture or avascular necrosis
Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY
Traumatic joint destruction
Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty

Exclusion Criteria:

People with diminished mental faculties
Known current pregnancy
Breast-feeding
Neurological disorders or other pathologies that may influence locomotion
Septic antecedent on hip to operate
Patient requiring a bone graft

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

The implantation of the total hip prothesis will be performed in patients with a hip pathology in the first intention or during total prothesis revision

Sampling Method

Non-Probability Sample